A research clinic near you is currently enrolling participants for a clinical study on Tourette’s disorder. The study is evaluating a drug that is already approved by the FDA. This study will help researchers and physicians collect additional information about the safety and therapeutic benefits of long-term maintenance use of the drug.
Who can participate in this study?
Qualified participants must:
- Be 6 to 17 years old
- Be diagnosed with Tourette’s disorder of at least moderate severity that causes impairment to regular activities
- Not have other disorders that may impact the study (Huntington’s disease, traumatic brain injury, schizophrenia, bipolar disorder, etc.)
The study staff at a local research clinic will review your child’s complete medical history and conduct additional tests to see if they can be in the study.
How long does the study last?
The study will last about 8-10 months and requires approximately 17 visits to the research clinic. Most visits will be 1-3 hours long in order to conduct study-related activities.
Will the study cost anything?
The study drug and all study-related medical tests and procedures are provided at no cost to qualified participants. Reimbursement may be provided for study-related travel. The study staff will discuss this with you and your child in more detail.
How can I learn more?
Please contact a local study clinic to learn more about the study and to discuss your child’s eligibility.
About the Study Drug
The study drug being evaluated in this study has already been approved by the FDA. This study will help researchers and physicians collect additional information about long-term maintenance treatment of Tourette’s disorder.
The study will last up to 10 months and requires about 17 visits to the research clinic. Most visits will be 1-3 hours long in order to complete study assessments and conduct blood tests and other study-related procedures.
The study is divided into several phases:
- Screening Phase (3-42 days): Study entry criteria will be reviewed and confirmed, and your child may be asked to stop taking certain medications that are not allowed in the study.
- Stabilization Phase (14-20 weeks): Every participant will receive the study drug at measured amounts. The dose will increase based on how your child tolerates the study drug.
- Randomized Withdrawal Phase (up to 12 weeks): Your child will be randomly assigned (like flipping a coin) to receive the study drug or placebo (a substance that looks like the study drug but contains no active ingredient). Neither you nor the study doctor will know if your child is receiving the study drug or placebo.
- Follow-Up Phase: You will be contacted by phone 30 days after the last visit in the doubleblind Randomized Withdrawal Phase to find out how your child is feeling and if he or she has had any side effects.
About Clinical Research
Every day, people volunteer to participate in clinical research studies. This allows doctors to evaluate how certain drugs, treatments, or medical devices affect people. Before a study can begin, it must first be approved by a regulating agency such as the U.S. Food and Drug Administration. Safety is an important part of every research study, and patient health is monitored by doctors and nurses throughout the study.
Every clinical research study is monitored by a medical ethics committee called an IRB (institutional review board). The IRB’s job is to help protect the rights of participants, to protect their privacy, and to help ensure the study is conducted safely and ethically.
Your Rights and Your Child’s Rights
The study doctor and members of the study team will explain the study, risks, potential benefits, other treatment options, and your child’s right to withdraw. They will also answer all of your questions and your child’s questions, and will provide you with written information about the study.
If your child qualifies and you both agree to be part of the study, you will sign an informed consent form. By signing this form, it means you have been informed of the study details, including how your child’s data will be used, and that you agree to let your child participate. Your child will also sign a simplified version of this form called an “assent form.” The informed consent (and assent) is not a contract. You or your child may withdraw from the study at any time for any reason.
What are the potential benefits and risks of participating in a clinical research study?
You may not get any medical benefit by taking part in this study. It is not guaranteed that the study treatment with the study drug will help you directly. You may not receive study drug or you may/may not receive an alternative treatment. However, all participants will be followed closely. The information we get from this study may help us to improve the treatment for future patients who suffer from the same illness as you.
Taking part in a clinical study is completely voluntary. Participation is not required, and if enrolled in a clinical study, you or your child can choose to end participation at any time and for any reason.
Who is sponsoring this clinical study?
This study is being paid for by Otsuka Pharmaceutical Development & Commercialization, Inc.
About Tourette’s Disorder
Tourette’s disorder (also called TD, Tourette Syndrome, or just Tourette’s) is a condition of the brain that causes tics. A tic is a sudden, rapid, involuntary movement or noise. Tics associated with TD become most prominent in early childhood and worsen as time goes by. Tics tend to be at their worst around age 10. Depending on how severe the tics are, they can have a significant impact on a child’s ability to socialize. This can have an important influence on learning and social development.
Tourette Association of America http://www.tourette.org
NIH’s Tourette Syndrome Fact Sheet https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tourette-Syndrome-Fact-Sheet
CDC’s Tourette Syndrome Info https://www.cdc.gov/ncbddd/tourette/index.html