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COMPLETED Phase 2

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

NCT02996305 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • OTHER Placebo
  • DRUG OV101 Regimen 1
  • DRUG OV101 regimen 2

Study Locations (13)

Florida

  • Ovid Therapeutics Investigative Site — Gainesville
  • Ovid Therapeutics Investigative Site — Tampa

Massachusetts

  • Ovid Therapeutics Investigative Site — Boston
  • Ovid Therapeutics Investigative Site — Lexington

Arizona

  • Ovid Therapeutics Investigative Site — Phoenix

California

  • Ovid Therapeutics Investigative Site — San Diego

Georgia

  • Ovid Therapeutics Investigative Site — Atlanta

Illinois

  • Ovid Therapeutics Investigative Site — Chicago

Ohio

  • Ovid Therapeutics Investigative Site — Cincinnati

Pennsylvania

  • Ovid Therapeutics Investigative Site — Media

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2016-01
Est. Completion 2018-08-06
Phase Phase 2

Sponsor

Healx AI

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02996305

The ClinicalTrials.gov registry entry for NCT02996305 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Healx AI, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Angelman Syndrome appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02996305 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Florida, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02996305 about?

NCT02996305 is a clinical study titled "A Study in Adults and Adolescents With Angelman Syndrome (STARS)". 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.

What is the current status of trial NCT02996305?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2016-01. Estimated completion is 2018-08-06.

What conditions does trial NCT02996305 study?

This clinical trial studies the following conditions: Angelman Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02996305?

The interventions under investigation include: Placebo (OTHER), OV101 Regimen 1 (DRUG), OV101 regimen 2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02996305?

This trial is sponsored by Healx AI, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02996305 being conducted?

This trial has 13 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial