NCT04106557

A Study of OV101 in Individuals With Angelman Syndrome (AS)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Healx AI · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.

Conditions

• Primary Disease or Condition Being Studied: Angelman Syndrome (AS)

Interventions

Type	Name	Description
DRUG	Gaboxadol	OV101 versus placebo once daily at bedtime for 12 weeks
DRUG	Placebo	Matching placebo capsules to OV101 capsules.

Timeline

• Start date: 2019-09-09
• Primary completion: 2020-11-02
• Completion: 2020-11-02
• First posted: 2019-09-27
• Last updated: 2024-01-08
• Results posted: 2024-01-08

Locations

14 sites across 5 countries: United States, Australia, Germany, Israel, Netherlands

Regulatory

• FDA-regulated drug study