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

NCT04106557 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-01-08

Study results available
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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

DRUG

Gaboxadol

OV101 versus placebo once daily at bedtime for 12 weeks

DRUG

Placebo

Matching placebo capsules to OV101 capsules.

Sponsors & Collaborators

  • Healx AI

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2020-11-02
Completion
2020-11-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Israel
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106557 on ClinicalTrials.gov