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A Study in Adults and Adolescents With Angelman Syndrome (STARS) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02996305•Healx AI

View on ClinicalTrials.gov

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.

Eligibility

Age

13 - 49 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Age 13- 49 years
•2. Diagnosis of Angelman syndrome
•3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to Baseline, and able to maintain these throughout the duration of the study
•4. Has a caregiver capable of providing informed consent on behalf of the subject and able to attend scheduled study visits
•5. Able to ingest study medication
•6. Caregivers must agree not to post any subject or study information on social media

Exclusion Criteria

•1. Unable to perform the study related safety and exploratory efficacy assessments, such as motor function
•2. Poorly controlled seizure activity
•3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study
•4. Pregnancy or women of child-bearing potential who are not using and acceptable method of contraception
•5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, and cannabinoid derivatives, or any other use of any investigational agent, device, and/or investigational procedure 4 weeks prior to Baseline and during the study
•6. Allergy to OV101 or any excipients
•7. At increased risk of harming self and/or others based on investigator assessment
•8. Any condition or reason that in the opinion of the investigator makes the subject unsuitable for enrollment
•9. Inability of subject or caregiver to comply with study requirements

Locations (13)

Ovid Therapeutics Investigative Site

Phoenix, Arizona, United States

Ovid Therapeutics Investigative Site

San Diego, California, United States

Ovid Therapeutics Investigative Site

Gainesville, Florida, United States

Ovid Therapeutics Investigative Site

Tampa, Florida, United States

Ovid Therapeutics Investigative Site

Atlanta, Georgia, 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

Key Dates

Start Date

January 1, 2016

Primary Completion Date

June 7, 2018

Completion Date

August 6, 2018

Last Updated

August 3, 2025

Enrollment

88

ACTUAL participants

Conditions

Angelman Syndrome

Interventions

OV101 Regimen 1

DRUG

OV101 regimen 2

DRUG

Placebo

OTHER

Sponsors

Lead Sponsor

Healx AI

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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: August 3, 2025Data 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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