Tourette’s Disorder affects millions of children, adolescents, and adults around the world. Currently approved therapies for Tourette’s Disorder sometimes come with undesirable side effects, so there is a need for more research for this condition. Scientists are investigating a study drug called ecopipam for adults, adolescents, and children with Tourette’s Disorder. A study drug is one that is not yet approved for use by the general public. Ecopipam is designed to function differently than the currently approved therapies for individuals with Tourette’s Disorder. Scientists want to find out how it works over time and how safe it is for children, adolescents, and adults with Tourette’s Disorder. Pharmaceutical companies use clinical studies like this one to learn more about study drugs before they are made available to the public. Study participants can help us in this important research.
To qualify for this research study, you must:
This is not a complete list of study requirements. The study doctor will review the full study requirements with you. There is no cost to participate in this study. You do not have to pay for the study drug, study supplies, or tests that are part of the clinical study. Ask your doctor if you are eligible to participate in the Phase 3 D1AMOND study.
Participants will be in this study for approximately 8 months and will have up to 15 visits to the study site during that time. There will also be at least two telephone appointments during the study.
In the Phase 3 D1AMOND study, there will be four study periods. First, there is a screening period, which will last up to 28 days. During the screening period, doctors will decide if individuals are eligible to participate in the study.
Next is the open-label stabilization period, which will last around 12 weeks. During this period, all participants will receive the study drug, ecopipam.
The double-blind randomized withdrawal period will follow. It will last about 12 weeks. During this period, some participants will receive the study drug, ecopipam, and some will receive a placebo. A placebo is a substance that looks like the study drug but has no study drug in it. Participants will be chosen at random (by chance, like flipping a coin) to receive the study drug or the placebo.
The final portion of the study is the safety follow-up period, which will last about 30 days.
Participants who complete the study will have the opportunity to enter an extension study where all participants will receive the study drug.
Lab tests, physical exams, and other assessments and questionnaires will be conducted as part of this study.
You do not have to pay for the study drug, supplies, or tests that are part of the clinical study.
There are possible risks involved with any clinical study. The research doctor will review the risks with you, and you will be closely monitored by the research staff throughout the study.
Dinesh Sowdagar
Clinical Research Coordinator
Kids Clinic
905.683.4440
dsowdagar@kidsclinic.ca
Study ID: ebs-101-td-301