Clinical Trials Directory

Trials / Completed

CompletedNCT02996305

A Study in Adults and Adolescents With Angelman Syndrome (STARS)

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Healx AI · Industry
Sex
All
Age
13 Years – 49 Years
Healthy volunteers
Not accepted

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.

Detailed description

Two dosing schedules of OV101 (gaboxadol) giving as once daily or twice daily dose will be assessed against placebo.

Conditions

Interventions

TypeNameDescription
DRUGOV101 Regimen 1
DRUGOV101 regimen 2
OTHERPlacebo

Timeline

Start date
2016-01-01
Primary completion
2018-06-07
Completion
2018-08-06
First posted
2016-12-19
Last updated
2025-08-03
Results posted
2022-03-31

Locations

13 sites across 2 countries: United States, Israel

Source: ClinicalTrials.gov record NCT02996305. Inclusion in this directory is not an endorsement.