Phase 3 N=216 Randomized Triple-blind Treatment

Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

Tourette Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05615220 ↗

Enrolled (actual)

216

Serious AEs

1.3%

Results posted

Nov 2025

Primary outcome: 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 weeks

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ecopipam Hydrochloride (Drug)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Emalex Biosciences Inc.
Primary completion: Jan 2025

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05615220). 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.