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NCT05615220 · ClinicalTrials.gov registry record · Phase 3
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
A Phase 3 study, sponsored by Emalex Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT05615220: Completed Phase 3 study, sponsored by Emalex Biosciences.
NCT05615220 is a Phase 3 study that has completed, run by Emalex Biosciences. The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05615220, a Phase 3 study, has completed, sponsored by Emalex Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study Summary
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period.
Primary Outcome
Time to relapse defined as a loss of \>=50 percent (%) of the improvement experienced on the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) from Baseline to the last visit in the Open-Label Stabilization Period (Week 12), or initiation of additional medications to treat symptoms of Tourette's Disorder (TD), or requirement of hospitalization for worsening symptoms of TD in participants between the ages of \>= 6 and \<18 years for ecopipam compared to those receiving placebo during the
Interventions
- DRUG Ecopipam Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2025-02-04 |
| Phase | Phase 3 |
What the finished NCT05615220 record still lists
NCT05615220 is an interventional study that assigns participants to a tested intervention. The registered 216 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 (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Ecopipam Hydrochloride is the first listed.
NCT05615220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05615220 about?
NCT05615220 is a clinical study titled "Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults". This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by a double-blind, placebo-controlled, randomized withd...
What is the current status of trial NCT05615220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2023-01-31. Estimated completion is 2025-02-04.
What interventions are being tested in trial NCT05615220?
The interventions under investigation include: Ecopipam Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05615220?
This trial is sponsored by Emalex Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05615220's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 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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