Restless Legs Syndrome (RLS) Study for Teens
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 body’s response to and the safety and effectiveness of an investigational drug, for the treatment of RLS in teenagers.
At the end of this study, participants may be asked to take part in a follow-up study.
Who can participate?
Teens 13 to 17 years old who have been diagnosed with the type of RLS called idiopathic (no apparent cause) may be eligible to participate.
What is involved?
Your child will be in the research study for approximately 13 weeks. Participation in this research study will involve up to 13 visits. A detailed list of procedures will be provided to parents or guardians interested in knowing more about this study. Here are some of the procedures:
Your Child will:
- Receive the study drug in the form of a skin patch
- Have a physical exam
- Be measured for height and weight and have vital signs checked
- Have a neurological exam to check his/her reflexes and coordination
- Submit blood and urine samples
- Complete a questionnaire about his/her RLS and its effects
- Wear a wrist and leg activity monitor on some days during the study
- Be asked about whether he/she has had thoughts of suicide
- Be asked about whether he/she has acted compulsively (engaged in compulsive eating, compulsive buying, repetitive actions, etc.) during the time of the study
- Have an electrocardiogram (ECG), a recording of the electrical activity of his/her heart
You, as the parent, will provide general information about your child’s medical history and medications.
What are the benefits?
Your child may or may not receive a direct medical benefit from participating in this study. His/her RLS symptoms could improve, stay the same, or become worse. However, the information learned from this research study may benefit other teens with RLS 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, whom 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.
Do participants receive pay, compensation or reimbursement?
Families will receive pay for time and travel.
Who should I contact for more information?
Stephanie Funke
stephanie.funke@cchmc.org
513-803-1897
Clinical Trials Office
Cincinnati Children’s Hospital Medical Center, MLC 7004
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Principal Investigator
Narong Simakajornboon, MD
Division of Pulmonary Medicine
Cincinnati Children’s Hospital Medical Center
