Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04776746 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of Trofinetide for Rett Syndrome
A Phase 3 study, sponsored by ACADIA Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT04776746: Clinical Trial Phase 3 study, sponsored by ACADIA Pharmaceuticals.
NCT04776746 is a Phase 3 study that was terminated before completion, run by ACADIA Pharmaceuticals. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04776746, a Phase 3 study, was terminated before completion, sponsored by ACADIA Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study Summary
To investigate the safety and tolerability of continued long-term treatment with oral trofinetide in girls and women with Rett syndrome
Primary Outcome
Withdrawals due to AEs included both study drug discontinuation as well as study termination
Interventions
- DRUG trofinetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-11-08 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
Why NCT04776746 stopped before completion
NCT04776746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which trofinetide is the first listed.
NCT04776746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04776746 about?
NCT04776746 is a clinical study titled "Open-Label Extension Study of Trofinetide for Rett Syndrome". To investigate the safety and tolerability of continued long-term treatment with oral trofinetide in girls and women with Rett syndrome
What is the current status of trial NCT04776746?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2020-11-08. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT04776746?
The interventions under investigation include: trofinetide (DRUG).
Who is sponsoring clinical trial NCT04776746?
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 NCT04776746's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 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
- NCT02127398 · 77 participants · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
- NCT04159103 · 77 participants · Phase 1
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
- NCT04683003 · 77 participants · Phase 3
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT05004116 · 77 participants · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
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