Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT04106557
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of OV101 in Individuals With Angelman Syndrome (AS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C015542', 'term': 'gaboxadol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tbaumgartner@ovidrx.com', 'phone': '802-752-5168', 'title': 'Todd F. Baumgartner, M.D., MPH', 'organization': 'Ovid Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'OV101 Once Daily (Weight-based Dosing) Other Name:Gaboxadol', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration\n\nGaboxadol: OV101 versus placebo once daily at bedtime for 12 weeks Age (Actual) 4 to 12 Years at Screening', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 31, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Once Daily', 'description': 'Matching placebo,oral, provided once daily at bedtime for 12 week duration\n\nPlacebo: Matching placebo capsules to OV101 capsules.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 22, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'OV101 Once Daily (Weight-based Dosing) Age 2-3', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration Age (Actual) 2 to 3 Years at Screening', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Generalized tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Drooling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Prolonged aPTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}], 'seriousEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Global Impressions- Improvement in Angelman Syndrome (CGI-I-AS) Rating at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OV101 (Ages 4-12 Years, Inclusive)', 'description': 'ages 4-12 years, inclusive taking OV101'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'ages 4-12 years, taking Placebo'}], 'classes': [{'title': '1-Very much improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '2-Much improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '3-Minimally improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '4-No change', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '5-Minimally worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '6-Much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '7-Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'To evaluate the efficacy of OV101 versus placebo as assessed by the Clinical Global Impressions-Improvement-Angelman syndrome (CGI-I-AS) score at Week 12. CGIA-I-AS scores range from 1 (very much improved), to 4 (no change), to 7 (very much worse).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 97 subjects, ages 4-12 years, inclusive. Participants aged 2 to 3 (n=7) did not participate in the scoring.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OV101 Once Daily (Weight-based Dosing) Age 4 to 12', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration 4 to 12 years old'}, {'id': 'FG001', 'title': 'Placebo Once Daily', 'description': 'Matching placebo,oral, provided once daily at bedtime for 12 week duration\n\nPlacebo: Matching placebo capsules to OV101 capsules.'}, {'id': 'FG002', 'title': 'OV101 Once Daily (Weight-based Dosing) Age 2 to 3', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration 2 to 3 years old'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States, Australia, Germany, Israel, and Netherlands.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OV101 Once Daily (Weight-based Dosing) Age 4 to 12', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration\n\nGaboxadol: OV101 versus placebo once daily at bedtime for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo Once Daily', 'description': 'Matching placebo,oral, provided once daily at bedtime for 12 week duration\n\nPlacebo: Matching placebo capsules to OV101 capsules.'}, {'id': 'BG002', 'title': 'OV101 Once Daily (Weight-based Dosing) Age 2 to 3', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '4-8', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}, {'title': '9-12', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': '2-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients actual enroll'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-26', 'size': 1496546, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-15T19:01', 'hasProtocol': True}, {'date': '2020-10-15', 'size': 1590810, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-15T18:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant/Care Giver and Investigator/Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2019-09-25', 'resultsFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-05', 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impressions- Improvement in Angelman Syndrome (CGI-I-AS) Rating at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'To evaluate the efficacy of OV101 versus placebo as assessed by the Clinical Global Impressions-Improvement-Angelman syndrome (CGI-I-AS) score at Week 12. CGIA-I-AS scores range from 1 (very much improved), to 4 (no change), to 7 (very much worse).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Disease or Condition Being Studied: Angelman Syndrome (AS)']}, 'referencesModule': {'references': [{'pmid': '37639777', 'type': 'DERIVED', 'citation': 'Keary C, Bird LM, de Wit MC, Hatti S, Heimer G, Heussler H, Kolevzon A, Mathews A, Ochoa-Lubinoff C, Tan WH, Yan Y, Adams M. Gaboxadol in angelman syndrome: A double-blind, parallel-group, randomized placebo-controlled phase 3 study. Eur J Paediatr Neurol. 2023 Nov;47:6-12. doi: 10.1016/j.ejpn.2023.07.008. Epub 2023 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female and 2 to 12 years old (inclusive) at the time of informed consent\n* Confirmed molecular diagnosis of AS\n* Has a CGI-S-AS score of 3 or more at baseline.\n* Meets the following age-appropriate body weight criterion:\n\n 1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.\n 2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).\n* Stable concomitant mediations for at least 4 weeks before study start\n\nExclusion Criteria:\n\n* Any condition that would limit study participation\n* Clinically significant lab or vital sign abnormalities at the time of screening\n* Poorly controlled seizures (weekly seizures of any frequency with a duration more than 3 minutes, weekly seizures occurring more than 3 times per week, each with a duration of less than 3 minutes, or as defined by investigator assessment)\n* Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks prior to Day 1 or during the study. Benzodiazepines chronically administered for seizure control are permitted.\n* Cannot comply with protocol study assessments during screening or caregiver unable to comply with study requirements.\n* Enrolled in any clinical trial or used any investigational agent within the 30 days before screening or concurrently with this study.'}, 'identificationModule': {'nctId': 'NCT04106557', 'acronym': 'NEPTUNE', 'briefTitle': 'A Study of OV101 in Individuals With Angelman Syndrome (AS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healx AI'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome', 'orgStudyIdInfo': {'id': 'OV101-19-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OV101 once daily (weight-based dosing) Other Name:Gaboxadol', 'description': 'OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration', 'interventionNames': ['Drug: Gaboxadol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo once daily', 'description': 'Matching placebo,oral, provided once daily at bedtime for 12 week duration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gaboxadol', 'type': 'DRUG', 'description': 'OV101 versus placebo once daily at bedtime for 12 weeks', 'armGroupLabels': ['OV101 once daily (weight-based dosing) Other Name:Gaboxadol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules to OV101 capsules.', 'armGroupLabels': ['Placebo once daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92024', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02421', 'city': 'Lexington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 42.44732, 'lon': -71.2245}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '85006', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '4101', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '80804', 'city': 'Munich', 'country': 'Germany', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '3012CN', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Ovid Therapeutics Investigative Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healx AI', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}