Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05655520
Status:
TERMINATED
Last Update Posted:
2025-12-17
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gceresoliborroni@supernus.com', 'phone': '3018382521', 'title': 'Gianpiera Ceresoli-Borroni PhD', 'organization': 'Supernus Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 months', 'description': 'The Safety Set included all participants who were administered IP during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 46, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 22, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chorea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': "Huntington's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One TEAE by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': "A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as:\n\nMild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms.\n\nModerate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed.\n\nSevere: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized.\n\nParticipant with multiple instances of events is counted only once using maximum intensity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Withdrew From Study Due to TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs: Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'Change From Baseline (CFB): Systolic Blood Pressure (Supine)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '11.49', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '14.61', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Systolic Blood Pressure (Standing 1 minute)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '17.63', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '14.72', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Systolic Blood Pressure (Standing 3 minute)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '13.85', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '13.94', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Diastolic Blood Pressure (Supine)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '9.02', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Diastolic Blood Pressure (Standing 1 minute)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '11.41', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '10.27', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Diastolic Blood Pressure (Standing 3 minute)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '10.33', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '11.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last Value on Study (up to 24 months)', 'description': 'Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes).\n\nLast value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs: Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Heart Rate Supine', 'categories': [{'measurements': [{'value': '2.2', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '9.91', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Heart Rate Standing 1 Minute', 'categories': [{'measurements': [{'value': '1.8', 'spread': '13.13', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '11.45', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Heart Rate Standing 3 Minute', 'categories': [{'measurements': [{'value': '1.7', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '14.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute).\n\nLast value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs: Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Signs: Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '7.519', 'groupId': 'OG000'}, {'value': '0.058', 'spread': '0.3650', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for vital sign parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.052', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.101', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.2369', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.2312', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '1.609', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.328', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.317', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.362', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.134', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.115', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '1.561', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.230', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '37.38', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '30.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'cells*10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Basophils/Leukocytes', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.313', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.240', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Eosinophils/Leukocytes', 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.259', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '1.268', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Lymphocytes/Leukocytes', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '6.984', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '6.023', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Monocytes/Leukocytes', 'categories': [{'measurements': [{'value': '0.32', 'spread': '2.427', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.547', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Neutrophils/Leukocytes', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '8.792', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '7.208', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Ery. Mean Corpuscular HGB Concentration', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '11.85', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '9.24', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Hemoglobin', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '8.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.740', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.953', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'picograms (pg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '3.091', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '2.884', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'femtoliters (fL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0033', 'spread': '0.0256', 'groupId': 'OG000'}, {'value': '0.0055', 'spread': '0.0271', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'liters per liter (L/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '10.80', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '11.42', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '13.17', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '13.04', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '9.79', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Creatinine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.6', 'spread': '135.53', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '83.46', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Gamma Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '14.47', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '31.75', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '19.89', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '25.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.0905', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.0861', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.777', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.735', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.128', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '1.274', 'groupId': 'OG001'}]}]}, {'title': 'CFB: HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.188', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.218', 'groupId': 'OG001'}]}]}, {'title': 'CFB: LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.636', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.671', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.1688', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.1937', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.463', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.319', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.125', 'spread': '0.9411', 'groupId': 'OG000'}, {'value': '0.080', 'spread': '0.8615', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '1.371', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '1.344', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'HDL= high-density lipoprotein LDL= low-density lipoprotein\n\nLast value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Albumin', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Protein', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Bilirubin', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '3.149', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '2.912', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Creatinine', 'categories': [{'measurements': [{'value': '0.7', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '9.95', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Direct Bilirubin', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.201', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '1.223', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Indirect Bilirubin', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '2.367', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '2.137', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'micromoles per liter (µmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.061', 'spread': '2.2278', 'groupId': 'OG000'}, {'value': '-0.181', 'spread': '1.2943', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'milli-international units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Thyroxine, Free', 'categories': [{'measurements': [{'value': '2.55', 'spread': '20.153', 'groupId': 'OG000'}, {'value': '6.40', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated due to low number of participants available for analysis.', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Triiodothyronine, Free', 'categories': [{'measurements': [{'value': '0.85', 'spread': '1.909', 'groupId': 'OG000'}, {'value': '1.70', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated due to low number of participants available for analysis.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'picomoles per liter (pmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Erythrocytes in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Leukocytes in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.53', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Renal Epithelial Casts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Squamous Epithelial Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '16.29', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '4.98', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Transitional Epithelial Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'cells per high power field', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure and Number analyzed is the number of participants with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 milligrams (mg), orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'casts per low power field (/lpf)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.667', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.679', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: Activated Partial Thromboplastin Time', 'categories': [{'measurements': [{'value': '0.86', 'spread': '5.876', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '2.947', 'groupId': 'OG001'}]}]}, {'title': 'CFB: Prothrombin Time', 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.008', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.673', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.011', 'spread': '0.1071', 'groupId': 'OG000'}, {'value': '-0.011', 'spread': '0.0740', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'prothrombin intl normalized ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for clinical laboratory parameters for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '8.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'beats per minute (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for ECG parameter for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'CFB: PR Interval, Aggregate', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '13.39', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '12.94', 'groupId': 'OG001'}]}]}, {'title': 'CFB: QRS Duration, Aggregate', 'categories': [{'measurements': [{'value': '1.8', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '9.11', 'groupId': 'OG001'}]}]}, {'title': 'CFB: QT Interval, Aggregate', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '22.72', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '20.94', 'groupId': 'OG001'}]}]}, {'title': 'CFB: QTcF Interval, Aggregate', 'categories': [{'measurements': [{'value': '0.8', 'spread': '15.32', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '14.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.', 'unitOfMeasure': 'millisecond (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Overall number of participants analyzed are the participants who were evaluable for ECG parameter for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'OG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'classes': [{'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No suicidal ideation/behavior to No suicidal ideation/behavior', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No suicidal ideation/behavior to No suicidal ideation/behavior', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal ideation', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No suicidal ideation/behavior to No suicidal ideation/behavior', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal ideation', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No suicidal ideation/behavior to No suicidal ideation/behavior', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 395', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No suicidal ideation/behavior to No suicidal ideation/behavior', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Safety Follow-up (up to 24 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No suicidal ideation/behavior to No suicidal ideation/behavior', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation/behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to No suicidal ideation/behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Ideation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Behavior to Suicidal Behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months)', 'description': 'Columbia Suicide Severity Rating Scale evaluates and assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and post-baseline evaluation that focuses on suicidality since last study visit. C-SSRS includes "yes" or "no"\' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present \\[from 1 (minor physical damage) to 5 (death), with 5 being most severe\\]. If any of the available assessments in suicidal behavior is Yes, the category is considered as \'Suicidal behavior\'. If any of these available assessments in suicidal ideation is Yes but all available assessments in suicidal behavior is NO, the category is considered as \'Suicidal Ideation\'. Data is reported for only those timepoints where there was a change in assessment (response) from Baseline. Baseline is the worst of assessments done in any question in SI/SB prior to first dose of IP, excluding lifetime assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were administered IP during the study. Number analyzed is the number of participants with data available for analysis at specified timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 milligrams (mg), orally once daily from Day 1 onwards.'}, {'id': 'FG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '77'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '68'}]}]}], 'recruitmentDetails': "Participation of a study partner was optional in this study and was only to support completion of study activities and answer questions about the participant's condition. Only participants with Huntington's Disease enrolled in this study represented enrollment number. Data presented in all the sections of the results represents data exclusively collected and analyzed for participants with Huntington's Disease enrolled in this study.", 'preAssignmentDetails': 'A total of 165 participants were screened, of which, 153 participants were enrolled and received study treatment in either Cohort 1 (Direct rollover) or Cohort 2 (Gap rollover). The study was terminated early by the Sponsor and hence, no participants were enrolled in Cohort 3 (De novo) and therefore no data was collected and reported.\n\nNo additional milestone.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'BG001', 'title': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who signed the informed consent for study 718-CIH-301 after a gap of \\>7 days following the last day of the corresponding parent study were enrolled in this cohort. Participants received Sage-718, 0.9 mg, orally once daily from Day 1 onwards.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '8.02', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '9.21', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '8.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanice or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Set included all participants who were administered investigational product (IP) during the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-05', 'size': 5100006, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-19T11:15', 'hasProtocol': True}, {'date': '2025-02-12', 'size': 2789717, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-19T11:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'whyStopped': 'Internal company decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-12-09', 'resultsFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-02', 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 24 months', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.'}, {'measure': 'Number of Participants With at Least One TEAE by Severity', 'timeFrame': 'Up to 24 months', 'description': "A TEAE is defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. Severity was assessed as:\n\nMild: symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptoms.\n\nModerate: symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptoms may be needed.\n\nSevere: symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with IP; treatment for symptoms may be given and/or participant hospitalized.\n\nParticipant with multiple instances of events is counted only once using maximum intensity."}, {'measure': 'Number of Participants Who Withdrew From Study Due to TEAEs', 'timeFrame': 'Up to 24 months', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE with onset or after the start of IP or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.'}, {'measure': 'Change From Baseline in Vital Signs: Blood Pressure', 'timeFrame': 'Baseline; Last Value on Study (up to 24 months)', 'description': 'Vital signs parameter for blood pressure included systolic blood pressure (supine), systolic blood pressure (standing 1 minute), systolic blood pressure (standing 3 minutes), diastolic blood pressure (supine), diastolic blood pressure (standing 1 minute), and diastolic blood pressure (standing 3 minutes).\n\nLast value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Vital Signs: Heart Rate', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Vital signs for heart rate included heart rate (supine), heart rate (standing 1 minute), and heart rate (standing 3 minute).\n\nLast value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Vital Signs: Respiratory Rate', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Vital Signs: Temperature', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Basophils, Eosinophils, Erythrocytes, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Hematology- Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Hematology- Erythrocytes (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Hemoglobin', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Erythrocytes Mean Corpuscular Volume', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Hematology - Hematocrit', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase', 'timeFrame': 'Baseline, Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'HDL= high-density lipoprotein LDL= low-density lipoprotein\n\nLast value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Albumin and Protein', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyrotropin', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Biochemistry - Thyroxine Free, Triiodothyronine Free', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Erythrocytes in Urine, Leukocytes in Urine, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Urinalysis- Hyaline Casts', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Urinalysis- pH', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Coagulation- Activated Partial Thromboplastin Time, Prothrombin Time', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Clinical Laboratory Parameters: Coagulation- Prothrombin International (Intl) Normalized Ratio', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in Electrocardiograms (ECGs) Parameters: Mean Heart Rate', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Change From Baseline in ECG Parameters - PR Interval Aggregate, QRS Duration Aggregate, QT Interval Aggregate and QTcF Interval Aggregate', 'timeFrame': 'Baseline; Last value on study (up to 24 months)', 'description': 'Last value on study is defined as the last post-baseline value on or after the first dose of IP and on or before the last date of the study.'}, {'measure': 'Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Responses', 'timeFrame': 'Day 30, Day 60, Day 90, Day 365, Day 395, Safety Follow-up (up to 24 months)', 'description': 'Columbia Suicide Severity Rating Scale evaluates and assesses the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and post-baseline evaluation that focuses on suicidality since last study visit. C-SSRS includes "yes" or "no"\' responses for assessment of SI and SB as well as numeric ratings for severity of ideation. If present \\[from 1 (minor physical damage) to 5 (death), with 5 being most severe\\]. If any of the available assessments in suicidal behavior is Yes, the category is considered as \'Suicidal behavior\'. If any of these available assessments in suicidal ideation is Yes but all available assessments in suicidal behavior is NO, the category is considered as \'Suicidal Ideation\'. Data is reported for only those timepoints where there was a change in assessment (response) from Baseline. Baseline is the worst of assessments done in any question in SI/SB prior to first dose of IP, excluding lifetime assessment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Huntington's Disease", 'SAGE-718'], 'conditions': ["Huntington's Disease"]}, 'descriptionModule': {'briefSummary': "The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor all participants:\n\n* Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort.\n* Agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit.\n* Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study.\n* Be able to travel to the study center, and, judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.\n\nAdditional inclusion criteria for the de novo cohort (Cohort 3):\n\n* Be at least 25 years old, but not older than 65 years of age at Screening.\n\n * Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion ≥40\n * No features of juvenile HD\n* CAG-Age-Product (CAP) score ≥90, as calculated using the CAP formula: AGE × (CAG - 30) / 6.49.\n* At screening, scores of either: a) Unified Huntington's Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC)=13 and Montreal Cognitive Assessment (MoCA) ≤25 score, or b) UHDRS-TFC ≤12 and MoCA \\>25\n\nExclusion Criteria:\n\nFor all participants\n\n* Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to, Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease.\n* Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit.\n* Is known to be allergic to any of SAGE-718 excipients, including soy lecithin.\n* Receive any prohibited medications within 30 days of screening and during participation in the study.\n\nAdditional exclusion criteria for the de novo cohort (Cohort 3):\n\n* Have previous exposure to gene therapy, or have participated in any other HD investigational drug, biologic, or device trial within 180 days or a non-HD drug, biologic or device trial within 30 days or 5 half-lives (whichever is longer). Additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mRNA) splicing modifier will be excluded.\n\nNote: Participants with confirmation of enrolment in the placebo arm of these investigational trials would not be excluded.\n\nAdditional exclusion criteria for 718-CIH-201/202 completers (Cohorts 1 and 2):\n\n* Have one or more ongoing serious adverse events (SAEs) from the parent study.\n* Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance."}, 'identificationModule': {'nctId': 'NCT05655520', 'briefTitle': "A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': "A Phase 3, Multicenter, Open-label Safety Study to Evaluate the Long-term Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease", 'orgStudyIdInfo': {'id': '718-CIH-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (Direct Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who will sign the informed consent for study 718-CIH-301 ≤7 days after the last day of the corresponding parent study will be enrolled in this cohort. Participants will receive Sage-718, 0.9 milligrams (mg), orally once daily from Day 1 onwards.', 'interventionNames': ['Drug: SAGE-718']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (Gap Rollover)', 'description': 'Participants from the studies 718-CIH-201 (NCT05107128) and 718-CIH-202 (NCT05358821) who will sign the informed consent for study 718-CIH-301 after a gap of \\>7 days after the last day of the corresponding parent study will be enrolled in this cohort. Participants will receive Sage-718 0.9 mg, orally once daily from Day 1 onwards.', 'interventionNames': ['Drug: SAGE-718']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (De Novo)', 'description': 'Participants who were not previously included in any SAGE-718 clinical study. Participants will receive Sage-718 from Day 1 onwards.', 'interventionNames': ['Drug: SAGE-718']}], 'interventions': [{'name': 'SAGE-718', 'type': 'DRUG', 'description': 'Oral softgel lipid capsules', 'armGroupLabels': ['Cohort 1 (Direct Rollover)', 'Cohort 2 (Gap Rollover)', 'Cohort 3 (De Novo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Sage 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'Australia', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'B3S1N2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M2K 1E1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X1R9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'PL6 8BT', 'city': 'Plymouth', 'state': 'Derriford', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SW17 0QT', 'city': 'Tooting', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 51.42524, 'lon': -0.16394}}, {'zip': 'AB25 2ZA', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'NE6 4QD', 'city': 'Newcastle', 'state': 'Upon Tyne', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'CF144XW', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'B15 2FG', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'LS7 4SA', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing will be consistent with the results submission policy of ClinicalTrials.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}