Trials / Completed
CompletedNCT04181723
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- ACADIA Pharmaceuticals Inc. · Industry
- Sex
- Female
- Age
- 5 Years – 20 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trofinetide | Trofinetide solution administered based on the subject's weight at Baseline, twice daily for 12 weeks |
| OTHER | Placebo | Trofinetide placebo solution administered based on the subject's weight at Baseline, twice daily for 12 weeks |
Timeline
- Start date
- 2019-11-06
- Primary completion
- 2021-10-28
- Completion
- 2021-10-28
- First posted
- 2019-11-29
- Last updated
- 2024-04-08
- Results posted
- 2024-04-08
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04181723. Inclusion in this directory is not an endorsement.