At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 104 enrolled
Drug / intervention
Gaboxadol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Gaboxadol and Placebo for Primary Disease or Condition Being Studied: Angelman Syndrome (AS). Completed, enrolled 104 participants across 14 sites in 5 countries.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Germany, Israel, Netherlands, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartSep 2019
First PostedSep 2019
Primary CompletionNov 2020
TodayJul 2026
First PostedSep 27, 2019
Enrollment StartSep 9, 2019
Primary CompletionNov 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.8 years ago
Interventions
Gaboxadoldrug
OV101 versus placebo once daily at bedtime for 12 weeks
Placebodrug
Matching placebo capsules to OV101 capsules.