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Expanded Access Program for Treatment With Ecopipam for Tourette's Disorder

NCT07093541 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-05-18

No results posted yet for this study

Summary

The goal of this expanded access study is to learn about the long-term effects of Ecopipam in participants with Tourette's Disorder (TD). The main question it aims to answer is:

* Is ecopipam safe and well-tolerated in participants equal and over the age of 6 to 50 with TD?
* Assess quality of life measures and to provide access to ecopipam while NDA is being prepared and submitted for review for marketing approval

Eligible participants with TD will take ecopipam with guidance from their treating physician. In addition to the standard of care from the treating physician, treatment with ecopipam will continue until ecopipam becomes commercially available in the United States or the program is terminated.

While in the EAP program, participants will be asked regarding how safe and tolerable ecopipam is to the participant. Several questionnaires will be collected regarding participants experiences while taking ecopipam during monthly visits for the first year and every three months thereafter until the conclusion of the study.

Conditions

  • Tourettes Disorder
  • Tourette Disorder

Interventions

DRUG

ecopipam HCl ~2mg/kg/day

Daily oral tablet taken every evening before bedtime.

Sponsors & Collaborators

  • Emalex Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Atkinson, MD · Emalex Biosciences

Eligibility

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

Timeline & Regulatory

Countries

  • United States

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 NCT07093541 on ClinicalTrials.gov