FindTrial
Sign In

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults with Tourette’s Disorder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503494-38-00
Acronym
EBS-101-TD-301
Enrollment
99
Registered
2023-06-02
Start date
2023-07-20
Completion date
2025-01-16
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette’s Disorder

Brief summary

Time from Randomization (Week 12) to Relapse in subjects ≥ 6 and < 18 years for ecopipam compared to placebo during the double-blind, R/WD period.

Detailed description

Time from Randomization (Week 12) to Relapse in all subjects irrespective of age for ecopipam compared to placebo during the double-blind R/WD period.

Interventions

DRUGEcopipam 67.2 mg
DRUGEcopipam 22.4 mg
DRUGEcopipam 11.2 mg
DRUGEcopipam 89.6 mg
DRUGEcopipam Placebo tablet oral use
DRUGEcopipam 44.8 mg
DRUGEcopipam 33.6 mg

Sponsors

Emalex Biosciences Inc., Emalex Biosciences Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Time from Randomization (Week 12) to Relapse in subjects ≥ 6 and < 18 years for ecopipam compared to placebo during the double-blind, R/WD period.—

Secondary

MeasureTime frame
Time from Randomization (Week 12) to Relapse in all subjects irrespective of age for ecopipam compared to placebo during the double-blind R/WD period.—

Countries

Bulgaria, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026