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

NCT02996305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-08-03

Study results available
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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.

Conditions

Interventions

DRUG

OV101 Regimen 1

DRUG

OV101 regimen 2

OTHER

Placebo

Sponsors & Collaborators

  • Healx AI

    lead INDUSTRY

Principal Investigators

  • Amit Rakhit, MD, MBA · Healx AI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-06-07
Completion
2018-08-06

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT02996305 on ClinicalTrials.gov