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NCT04181723 · ClinicalTrials.gov registry record · Phase 3
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
A Phase 3 study, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
NCT04181723: Completed Phase 3 study, sponsored by ACADIA Pharmaceuticals.
NCT04181723 is a Phase 3 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 187 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04181723, a Phase 3 study, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
Study Summary
To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome
Primary Outcome
The RSBQ is a 45-item caregiver-completed rating scale that includes 45 items, 39 of them grouped into 8 subscales, whose ratings reflect the severity and frequency of symptoms. Items are rated as 0 (not true), 1 (somewhat or sometimes true), or 2 (very true). The 8 subscales are general mood, breathing problems, hand behavior, face movements, body rocking/expressionless face, night-time behaviors, fear/anxiety, and walking/standing. Scores for item 31 are reversed in the calculation of the tota
Interventions
- OTHER Placebo
- DRUG Trofinetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2019-11-06 |
| Est. Completion | 2021-10-28 |
| Phase | Phase 3 |
What the finished NCT04181723 record still lists
NCT04181723 is an interventional study that assigns participants to a tested intervention. The registered 187 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04181723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04181723 about?
NCT04181723 is a clinical study titled "Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)". To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome
What is the current status of trial NCT04181723?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2019-11-06. Estimated completion is 2021-10-28.
What interventions are being tested in trial NCT04181723?
The interventions under investigation include: Placebo (OTHER), Trofinetide (DRUG).
Who is sponsoring clinical trial NCT04181723?
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 NCT04181723's enrollment target sits among peer trials
187 1410th of 2000 higher than 589 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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