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NCT02996305 · ClinicalTrials.gov registry record · Phase 2
A Study in Adults and Adolescents With Angelman Syndrome (STARS)
A Phase 2 study of Angelman Syndrome, sponsored by Healx AI.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 13
- Study locations
NCT02996305: Completed Phase 2 study of Angelman Syndrome, sponsored by Healx AI.
NCT02996305 is a Phase 2 study of Angelman Syndrome that has completed, run by Healx AI. The registered enrollment target is 88 participants, below the 118-participant average among 11 other Angelman Syndrome trials with a reported enrollment target (25% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996305, a Phase 2 study of Angelman Syndrome, has completed, sponsored by Healx AI.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
Summary of Subjects Reporting at least one Treatment Emergent Adverse Event (TEAEs), Safety Set. The table below summarizes the subjects who experienced TEAEs in the study.
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
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-08-06 |
| Phase | Phase 2 |
What the finished NCT02996305 record still lists
NCT02996305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 118-participant average among 11 other Angelman Syndrome trials with a reported enrollment target (25% lower).
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.
NCT02996305 lists 13 locations in 11 states (Florida, Massachusetts, Arizona).
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.
What interventions are being tested in trial NCT02996305?
The interventions under investigation include: Placebo (OTHER), OV101 Regimen 1 (DRUG), OV101 regimen 2 (DRUG).
Who is sponsoring clinical trial NCT02996305?
This trial is sponsored by Healx AI, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Angelman Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02996305's enrollment target sits among peer trials
88 7th of 11 higher than 5 of 11 other Angelman Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Angelman Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Safety and Efficacy Study of GTX-102 in Subjects With Deletion- or Nondeletion-type Angelman Syndrome (AS)
RECRUITING · Phase 2
-
Angelman Syndrome Natural History Study
RECRUITING
-
REVEAL: A Phase 3 Study of ION582 in Angelman Syndrome
RECRUITING · Phase 3
-
A Phase 1/2 Study of the Safety and Efficacy of MVX-220 in Angelman Syndrome
RECRUITING · Phase 1
-
Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)
RECRUITING · NA
-
HALOS: A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Ascending Doses of ION582 in Participants With Angelman Syndrome
RECRUITING · Phase 1
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