CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
OV101 Regimen 1 +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 13–49 years
  • ✓Diagnosis of Angelman syndrome confirmed
  • ✓Stable concomitant medications for at least 4 weeks before baseline and able to maintain throughout study
  • ✓Caregiver capable of providing informed consent and attending scheduled study visits
Key exclusion· 6
  • ✕Unable to perform study safety and exploratory efficacy assessments such as motor function
  • ✕Poorly controlled seizure activity
  • ✕Significant cardiovascular, respiratory, liver, renal, or hematologic disease that would limit study participation
  • ✕Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, or cannabinoid derivatives within 4 weeks prior to baseline and during study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02996305
NCT02996305Phase 2Completed
CompareCT.gov

A Phase 2 Adult and Adolescent Angelman Syndrome Clinical Trial: A Randomized, Double-Blind, Safety and Efficacy Study of Gaboxadol

Healx AI·interventional·Posted Dec 19, 2016·Updated Aug 3, 2025

In Brief

A Phase 2 clinical trial evaluating OV101 Regimen 1, OV101 regimen 2, and 1 other intervention for Angelman Syndrome. Completed, enrolled 88 participants across 13 sites in 2 countries.

Detailed Summary

The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAngelman Syndrome
CountriesIsrael, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 19, 2016
Enrollment StartJan 1, 2016
Primary CompletionJun 7, 2018
Study CompletionAug 6, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.5 years ago

Interventions

OV101 Regimen 1drug

OV101 regimen 2drug

Placeboother