Expanded Access Program for Treatment With Ecopipam for Tourette's Disorder
EBS-101-TD-392
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
1 other identifier
expanded_access
N/A
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedMarch 11, 2026
March 1, 2026
July 10, 2025
March 10, 2026
Conditions
Keywords
Interventions
Daily oral tablet taken every evening before bedtime.
Eligibility Criteria
You may qualify if:
- Age 6 to 50 years old inclusive at the time of informed consent/assent.
- Participant must sign/date the most current Informed Consent Form (ICF). For minor participants the LAR must/sign date the most current consent and the participant must sign/date the most current age-appropriate assent.
- In the opinion of the principal investigator (PI), the participant or in the case of a minor their LAR is capable of understanding and complying with protocol and program requirements, oral drug administration and care instructions.
- Weight ≥18 kg (39.6 lbs.).
- In the opinion of the PI, the participant meets diagnostic criteria for Tourette's Syndrome (TS) per Diagnostic and Statistical manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria for TD).
- The participant must have been treated with an FDA-approved treatment for TD (aripiprazole, haloperidol, or pimozide) or any other D2r antagonist (D2rA) and have experienced treatment failure, tolerability or safety issues as per LAR, participant or prescribing clinician or not have access to any of these approved medications.
- Females of child-bearing potential must have a negative urine pregnancy test at Screening.
- Females of child-bearing potential who are sexually active or become sexually active must be using double barrier method (condom and IUD, condom and spermicide, etc.) in addition to any oral contraceptive they may be using and agree to continue use of double barrier contraception for the duration of their participation in the study and for 30 days after their last dose of study drug. Females of non-childbearing potential are exempt from this criterion.
- Non-Childbearing potential is defined by:
- Post menopausal defined as \>= 2 years amenorrheic, or,
- Bilateral salpingo-oopherectomy, or
- Hysterectomy, or
- Pre-menarche
- Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
- Male participants must agree to not donate sperm and female participants not to donate eggs for at least 30 days after the last dose of study drug.
- +49 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Cortica Glendale
Glendale, California, 91203, United States
Cortica Marin
San Rafael, California, 94903, United States
Yale Child Study Center
New Haven, Connecticut, 06511, United States
Parkinson's Center of Boca Raton
Boca Raton, Florida, 33486, United States
University of Miami
Miami, Florida, 33136, United States
University of South Florida
St. Petersburg, Florida, 33486, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago (Pritzker)
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts- Memorial Health
Worcester, Massachusetts, 01655, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3039, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Access Clinical Trials, INC
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
BCM-Texas Children's Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarah Atkinson, MD
Emalex Biosciences
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2025
First Posted
July 30, 2025
Last Updated
March 11, 2026
Record last verified: 2026-03