Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04106557 · ClinicalTrials.gov registry record · Phase 3
A Study of OV101 in Individuals With Angelman Syndrome (AS)
A Phase 3 study, sponsored by Healx AI.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT04106557: Completed Phase 3 study, sponsored by Healx AI.
NCT04106557 is a Phase 3 study that has completed, run by Healx AI. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04106557, a Phase 3 study, has completed, sponsored by Healx AI.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
Primary Outcome
To evaluate the efficacy of OV101 versus placebo as assessed by the Clinical Global Impressions-Improvement-Angelman syndrome (CGI-I-AS) score at Week 12. CGIA-I-AS scores range from 1 (very much improved), to 4 (no change), to 7 (very much worse).
Interventions
- DRUG Placebo
- DRUG Gaboxadol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2020-11-02 |
| Phase | Phase 3 |
What the finished NCT04106557 record still lists
NCT04106557 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04106557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04106557 about?
NCT04106557 is a clinical study titled "A Study of OV101 in Individuals With Angelman Syndrome (AS)". The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
What is the current status of trial NCT04106557?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2019-09-09. Estimated completion is 2020-11-02.
What interventions are being tested in trial NCT04106557?
The interventions under investigation include: Placebo (DRUG), Gaboxadol (DRUG).
Who is sponsoring clinical trial NCT04106557?
This trial is sponsored by Healx AI, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04106557's enrollment target sits among peer trials
104 1671st of 2000 higher than 327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03403686 · 104 participants
Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)
- NCT04228367 · 104 participants · NA
JuggerStitch Post Market Clinical Follow-up Study
- NCT04268849 · 104 participants · Phase 3
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- NCT04390724 · 104 participants
Optimizing Y90 Therapy for Radiation Lobectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI