Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT03787758
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2018-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.', 'timeFrame': '21 Days'}, {'measure': 'Percentage of participants with change from baseline in vital signs.', 'timeFrame': '21 Days'}, {'measure': 'Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities', 'timeFrame': '21 Days'}, {'measure': 'Percentage of participants with change from baseline in clinical laboratory parameters.', 'timeFrame': '21 Days'}, {'measure': 'Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).', 'timeFrame': '21 Days'}], 'secondaryOutcomes': [{'measure': 'PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].', 'timeFrame': '17 Days'}, {'measure': 'PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].', 'timeFrame': '17 Days'}, {'measure': 'PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].', 'timeFrame': '17 Days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Huntington Disease']}, 'referencesModule': {'references': [{'pmid': '38988035', 'type': 'DERIVED', 'citation': "Koenig A, Lewis M, Wald J, Li S, Varoglu M, Dai J, Sankoh A, Paumier K, Doherty J, Quirk M. Dalzanemdor (SAGE-718), a novel, investigational N-methyl-D-aspartate receptor positive allosteric modulator: Safety, tolerability, and clinical pharmacology in randomized dose-finding studies in healthy participants and an open-label study in participants with Huntington's disease. Clin Transl Sci. 2024 Jul;17(7):e13852. doi: 10.1111/cts.13852."}]}, 'descriptionModule': {'briefSummary': "This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)", 'detailedDescription': 'This posting addresses Part B'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units).\n2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.\n\nExclusion Criteria:\n\n1. Subject has any clinically significant abnormal finding on the physical exam at screening or admission.\n2. Subject has a history or presence of a neurologic disease or condition (other than Huntington's disease), including but not limited to severe chorea, epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.\n3. Subject has a family history of epilepsy.\n4. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission."}, 'identificationModule': {'nctId': 'NCT03787758', 'briefTitle': "A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B", 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': "A Phase 1, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Healthy Adults With an Open-label Cohort of Patients With Huntington's Disease", 'orgStudyIdInfo': {'id': '718-CLP-102 B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAGE-718', 'interventionNames': ['Drug: SAGE-718']}], 'interventions': [{'name': 'SAGE-718', 'type': 'DRUG', 'description': 'SAGE-718', 'armGroupLabels': ['SAGE-718']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}]}, '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'}}}}