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Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension

NCT04114539 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-02-01

Study results available
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Summary

This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

Conditions

  • Tourette Syndrome in Children
  • Tourette Syndrome in Adolescence

Interventions

DRUG

Ecopipam

Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.

Sponsors & Collaborators

  • Emalex Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2022-11-11
Completion
2022-11-11
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Poland

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 NCT04114539 on ClinicalTrials.gov