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A Study of OV101 in Individuals With Angelman Syndrome (AS) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT04106557•Healx AI

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

2 - 12 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Male or female and 2 to 12 years old (inclusive) at the time of informed consent
•Confirmed molecular diagnosis of AS
•Has a CGI-S-AS score of 3 or more at baseline.
•Meets the following age-appropriate body weight criterion:
•1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
•2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).
•Stable concomitant mediations for at least 4 weeks before study start

Exclusion Criteria

•Any condition that would limit study participation
•Clinically significant lab or vital sign abnormalities at the time of screening
•Poorly controlled seizures (weekly seizures of any frequency with a duration more than 3 minutes, weekly seizures occurring more than 3 times per week, each with a duration of less than 3 minutes, or as defined by investigator assessment)
•Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks prior to Day 1 or during the study. Benzodiazepines chronically administered for seizure control are permitted.
•Cannot comply with protocol study assessments during screening or caregiver unable to comply with study requirements.
•Enrolled in any clinical trial or used any investigational agent within the 30 days before screening or concurrently with this study.

Locations (14)

Ovid Therapeutics Investigative Site

Phoenix, Arizona, United States

Ovid Therapeutics Investigative Site

San Diego, California, United States

Ovid Therapeutics Investigative Site

Chicago, Illinois, United States

Ovid Therapeutics Investigative Site

Boston, Massachusetts, United States

Ovid Therapeutics Investigative Site

Lexington, Massachusetts, United States

Ovid Therapeutics Investigative Site

Cincinnati, Ohio, United States

Ovid Therapeutics Investigative Site

Media, Pennsylvania, United States

Ovid Therapeutics Investigative Site

Nashville, Tennessee, United States

Ovid Therapeutics Investigative Site

Tacoma, Washington, United States

Ovid Therapeutics Investigative Site

Brisbane, Queensland, Australia

Key Dates

Start Date

September 9, 2019

Primary Completion Date

November 2, 2020

Completion Date

November 2, 2020

Last Updated

January 8, 2024

Enrollment

104

ACTUAL participants

Conditions

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

Interventions

Gaboxadol

DRUG

Placebo

DRUG

Sponsors

Lead Sponsor

Healx AI

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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