Trials / Terminated
TerminatedNCT04776746
Open-Label Extension Study of Trofinetide for Rett Syndrome
An Open-Label Extension Study of Continuing Treatment With Trofinetide for Rett Syndrome
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- ACADIA Pharmaceuticals Inc. · Industry
- Sex
- Female
- Age
- 5 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the safety and tolerability of continued long-term treatment with oral trofinetide in girls and women with Rett syndrome
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trofinetide | Study drug is administered twice a day for up to approximately 32 months. Doses may be taken orally or administered by gastrostomy (G) tube. The subject's assigned dose for this study will be the final dose from the antecedent study (ACP-2566-004). |
Timeline
- Start date
- 2020-11-08
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2021-03-02
- Last updated
- 2024-09-27
- Results posted
- 2024-09-27
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04776746. Inclusion in this directory is not an endorsement.