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

ClinicalTrials.gov ID: NCT07093541

Public ClinicalTrials.gov record NCT07093541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 14, 2026, 7:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label Expanded Access Program Intended to Provide Treatment With Ecopipam (EBS-101) to Children, Adolescents, and Adults in the U.S. With Tourette's Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07093541
Recruitment status
Available
Study type
Expanded access
Phase
Not listed
Lead sponsor
Emalex Biosciences Inc.
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 50 Years
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
May 17, 2026

United States locations

U.S. sites
26
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
Cortica Glendale Glendale California 91203 Available
Cortica Marin San Rafael California 94903 Available
Yale Child Study Center New Haven Connecticut 06511 Available
Parkinson's Center of Boca Raton Boca Raton Florida 33486 Available
University of Miami Miami Florida 33136 Available
Belkis Delgado, MD, PA Miami Florida 33166 Available
University of South Florida St. Petersburg Florida 33486 Available
Emory University Atlanta Georgia 30329 Available
Northwestern University Chicago Illinois 60611 Available
University of Chicago (Pritzker) Chicago Illinois 60637 Available
Norton Children's Research Institute Louisville Kentucky 40202 Available
Johns Hopkins Hospital Baltimore Maryland 21287 Available
Massachusetts General Hospital Boston Massachusetts 02114 Available
Boston Children's Hospital Boston Massachusetts 02115 Available
University of Massachusetts- Memorial Health Worcester Massachusetts 01655 Available
Neurobehavioral Medicine Group Bloomfield Hills Michigan 48302 Available
Washington University in St. Louis St Louis Missouri 63110 Available
NYU Langone New York New York 10016 Available
Mount Sinai New York New York 10019 Available
Stony Brook Medicine Stony Brook New York 11794 Available
Cincinnati Children's Hospital Cincinnati Ohio 45229-3039 Available
North Star Medical Research, LLC Middleburg Heights Ohio 44130 Available
Providence Portland Oregon 97225 Available
Access Clinical Trials, INC Nashville Tennessee 37203 Available
Vanderbilt University Medical Center Nashville Tennessee 37232 Available
BCM-Texas Children's Hospital Houston Texas 77030 Available

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07093541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 17, 2026 · Synced Sep 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07093541 live on ClinicalTrials.gov.

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