Clinical Trial TitleA 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 / Protocol No. EBS-101-TD-301
National Clinical Trial Number:NCT05615220
Clinical Trial Protocol Description:
Tourette’s disorder (TD) is a problem with the nervous system (a part of your brain that controls your movements and thoughts) that causes people to make sudden repetitive movements or unwanted sounds that they cannot control. The purpose of this study is to learn how well ecopipam (an investigational drug; also called the study drug) works when taken continuously and how safe the study drug is compared with placebo (an inactive pill).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- If <18 years of age, the subject’s parent or legal guardian must sign a written informed consent and the subject must sign a written informed assent according to the requirements of the site’s IRB/EC.
- Are ≥6 years of age at time of screening.
- Weigh ≥18 kg (39.6 lbs).
- Have TD based on the DSM-5 diagnostic criteria for TD.
You will be excluded from the study if any of the following criteria apply to you:
- Have previous exposure to ecopipam (e.g., participated in study PSY301, PSY302 or EBS-101-CL-001).
- Have any unstable mood disorder at Screening or Baseline.
- Have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening as determined by the PI (Principal Investigator).
- Havea significant risk of attempting suicide based on history, routine psychiatric status examination, or investigator’s judgment.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.