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NCT04279314 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
A Phase 3 study, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 154
- Enrollment target
NCT04279314: Completed Phase 3 study, sponsored by ACADIA Pharmaceuticals.
NCT04279314 is a Phase 3 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 154 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04279314, a Phase 3 study, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 154 participants
- Enrollment target
Study Summary
To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls and women with Rett syndrome
Primary Outcome
Percentage of subjects with treatment-emergent adverse events (TEAEs), percentage of subjects with serious adverse events (SAEs), and percentage of subjects with withdrawals due to AEs
Interventions
- DRUG Trofinetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2020-01-29 |
| Est. Completion | 2022-08-19 |
| Phase | Phase 3 |
What the finished NCT04279314 record still lists
NCT04279314 is an interventional study that assigns participants to a tested intervention. The registered 154 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Trofinetide is the first listed.
NCT04279314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04279314 about?
NCT04279314 is a clinical study titled "Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome". To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls and women with Rett syndrome
What is the current status of trial NCT04279314?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2020-01-29. Estimated completion is 2022-08-19.
What interventions are being tested in trial NCT04279314?
The interventions under investigation include: Trofinetide (DRUG).
Who is sponsoring clinical trial NCT04279314?
This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04279314's enrollment target sits among peer trials
154 1509th of 2000 higher than 491 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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