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

NCT05615220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-11-25

Study results available
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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.

Conditions

  • Tourette Disorder

Interventions

DRUG

Ecopipam Hydrochloride

Selective dopamine D1 and D5 receptor antagonist

Sponsors & Collaborators

  • Emalex Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-01-13
Completion
2025-02-04
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615220 on ClinicalTrials.gov