Trials / Completed
CompletedNCT04279314
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
A 40-Week, Open-label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (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 long-term treatment with oral trofinetide in girls and women with Rett syndrome
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trofinetide | Trofinetide solution of 30-60 mL based on subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube) |
Timeline
- Start date
- 2020-01-29
- Primary completion
- 2022-08-19
- Completion
- 2022-08-19
- First posted
- 2020-02-21
- Last updated
- 2024-04-11
- Results posted
- 2024-04-11
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04279314. Inclusion in this directory is not an endorsement.