Clinical Trial TitleStudy of the efficacy and safety of a dopamine antagonist called ecopipam compared to placebo in the treatment of Tourette’s syndrome in children aged ≥6 to <17 years.
National Clinical Trial Number:NCT04007991
Clinical Trial Protocol Description:
The purpose of this study is to determine the efficacy and safety of ecopipam compared to placebo in children and adolescents with Tourette’s syndrome. The study will enroll 150 patients throughout the US and Europe. At Rush University Medical Center, we expect to recruit approximately 3 patients. The treatment will be assigned randomly.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are between the ages of 6 and 18 years of age at time of screening.
- Weigh ≥18 kg (39.6 lbs).
- Have Tourette’s syndrome (TS) based on Diagnostic and Statistical Manual for Mental Disorders – 5th Edition (DSM-5 diagnostic criteria) for TS.
- Exhibit both motor and vocal tics that cause impairment with normal routines.
You will be excluded from the study if any of the following criteria apply to you:
- Have any primary mood disorder (DSM-5 criteria) at screening.
- Have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at screening.
- Are someone with a significant risk of committing suicide based on history, routine psychiatric status examination, investigator’s judgment, or who had an answer of ‘‘yes’’ on any question other than 1–3 (currently or within the past 30 days) on the baseline/screening version of the Columbia Suicide Severity Rating Scale (C-SSRS).
- Have a clinical presentation at Screening and/or history consistent with another neurologic condition that may have had accompanying abnormal movements (e.g., Huntington’s disease, Parkinson’s disease, Wilson’s disease, stroke, Restless Legs Syndrome).
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.