Phase 3
Completed N=216
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Tourette Disorder
Source: ClinicalTrials.gov NCT05615220 ↗
Enrolled (actual)
216
Serious AEs
1.3%
Results posted
Nov 2025
Primary outcomePrimary: Time From Randomization to Relapse in Participants Greater Than and Equal to (>=) 6 and Less Than (<) 18 Years During the Double-Blind R/WD — NA; 4.0 weeks
◆ Published Evidence
Not yet cited
0citations
Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial.
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.
Linked Publications
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Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Relapse in Participants Greater Than and Equal to (>=) 6 and Less Than (<) 18 Years During the Double-Blind R/WD |
NA; 4.0 | — |
| SECONDARY Time From Randomization to Relapse in All Participants During the Double-Blind R/WD Period |
NA; 4.0 | — |
Eligibility Criteria
Inclusion Criteria
- ≥ 6 years of age
- ≥ 18 kg (~ 40 lbs.)
- TD diagnosis and both motor and vocal tics that cause impairment with normal routines
- Minimum score of 20 on the YGTSS-R Total Tic Score
- May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
- Effective contraception during the study and 30 days after last study dose for sexually active subjects
Exclusion Criteria
- Previous exposure to ecopipam
- Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
- Unstable medical illness or clinically significant lab abnormalities
- Risk of suicide
- Pregnant or lactating women
- Moderate to severe renal insufficiency
- Hepatic insufficiency
- Positive urine drug screen
- Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
- Certain medications that would lead to drug interactions
- Recent behavioral therapy
Data sourced from ClinicalTrials.gov (NCT05615220) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.