Studying the Safety and Efficacy of Ecopipam in Children, Adolescents, and Adults with Tourette's Disorder in a Randomized Trial
Summary
This Phase 3 multi-center study evaluates how well the medication ecopipam works to help treat tics in those with Tourette's disorder, and how safe the medication is. It is mainly a study for children and adolescents, but adults can also enroll in the study. There are several phases to the study:
•Screening Period: 1 month
•Open Label Stabilization Period: 12 weeks where all participants receive ecopipam
•Double-Blind Randomized Withdrawal Period: responders to ecopipam are randomized to either taking ecopipam versus taking placebo for 12 weeks
•Open-Label Extension Study: option for participants to roll into long-term open-label extension study, where all participants receive ecopipam
We will closely monitor all participants throughout the study.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 6 to 99
Inclusion criteria:
Study participation requirements:
•6 years of age or older
•18 kg (40 pounds) or more
•Diagnosis of Tourette's disorder (both motor and vocal tics for at least a year - tics need to cause impairment)
•Effective contraception for sexually active participants during the study (and 30 days after the last study dose)
Exclusion criteria:
Main exclusion criteria:
•Unstable mood disorder
•Bipolar disorder or psychosis
•Substance use disorder
•Suicide risk
•Unstable medical illness or clinically significant lab abnormalities
•History of seizures
•Using any other medication/treatment for tics
•Taking any prohibited medication (ADHD stimulant medication and many medications for depression/anxiety/OCD are acceptable, as long as dose is stable before/during study)
•Pregnant/lactating women
•Renal/hepatic insufficiency
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
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the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
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Additional information
Contact information
Tracy Hammer RN BN MEng BSc Clinical Research Coordinator – Registered Nurse Calgary Movement Disorders Research Group, Dr. Justyna Sarna HMRC, 5th Floor (5D05), Cal Wenzel Precision Health Building 3280 Hospital Drive NW Calgary, AB T2N 4Z6
Principal investigator:
Justyna Sarna
Clinical trial:
Yes
REB-ID:
REB22-1825