Tourette’s Syndrome Research Study for Children And Teens 7 to 17 Years Old
What is the purpose of this study?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to evaluate the safety and effectiveness of an investigational drug in the treatment of Tourette’s syndrome.
Who can participate?
Children and teenagers 7 to 17 years old who have been diagnosed with Tourette’s syndrome/disorder may be eligible to participate.
What is involved?
Your child will be in the research study for approximately 12 ½ to 18 weeks and have 11 study visits. He/she will be randomly assigned (like picking a number out of a hat) to either receive the study drug or placebo (a tablet that looks like the study drug but contains no active medication, sometimes calls a sugar pill). Your child will have 3 in 4 chances of receiving the active study drug. A detailed list of procedures will be provided to parents or guardians interested in knowing more about this study.
What are the benefits?
During your child’s participation in this study, his/her Tourette’s syndrome symptoms may be better controlled. However, your child may not receive a direct medical benefit, but the information learned from this research study may benefit other patients with Tourette’s syndrome in the future.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the risks and discomforts of the study?
Your child’s Tourette’s syndrome symptoms may not improve or may worsen while he/she is in this research study. The study drug aripiprazole (oral form) has been shown to be well tolerated; however, unwanted side effects may occur. A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.
Do participants receive pay, compensation or reimbursement?
Families will receive up to $450 for time and effort.
Who should I contact for more information?
Office for Clinical and Translational Research
Cincinnati Children’s Hospital Medical Center, MLC 7004
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Donald Gilbert, MD
Cincinnati Children’s Hospital Medical Center