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NCT03882918 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome
A Phase 3 study, sponsored by Healx AI.
- Terminated
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
NCT03882918: Clinical Trial Phase 3 study, sponsored by Healx AI.
NCT03882918 is a Phase 3 study that was terminated before completion, run by Healx AI. The registered enrollment target is 141 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03882918, a Phase 3 study, was terminated before completion, sponsored by Healx AI.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
Study Summary
This open-label study (OV101-18-002) will evaluate the long-term (52 weeks) safety of OV101 in subjects with AS and provide additional OV101 treatment to those subjects who completed Study OV101-15-001 (NCT02996305). Subjects with AS who completed the pharmacokinetic Study OV101-16-001 (NCT03109756) will also be permitted to participate, provided they meet all entry criteria.
Primary Outcome
Safety assessments related to the primary study objective of evaluating the safety and tolerability of OV101, including serious adverse events (SAEs) and adverse events (AEs) leading to study discontinuation, as assessed by the number of participants who experienced at least one adverse event.
Interventions
- DRUG OV101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
Why NCT03882918 stopped before completion
NCT03882918 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (82% lower).
The record links to 0 conditions, and to 1 intervention - of which OV101 is the first listed.
NCT03882918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03882918 about?
NCT03882918 is a clinical study titled "An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome". This open-label study (OV101-18-002) will evaluate the long-term (52 weeks) safety of OV101 in subjects with AS and provide additional OV101 treatment to those subjects who completed Study OV101-15-001 (NCT02996305). Subjects with AS who completed the pharmacokinetic Study OV101-16-001 (NCT03109756)...
What is the current status of trial NCT03882918?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2019-01-31. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03882918?
The interventions under investigation include: OV101 (DRUG).
Who is sponsoring clinical trial NCT03882918?
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 NCT03882918's enrollment target sits among peer trials
141 1563rd of 2000 higher than 436 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
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