Clinical Trials Office

Cerebral Palsy Research Study for Children and Teens

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting a research study to find out if an injectable medication can relax the calf muscle stiffness (spasticity) often experienced by children with cerebral palsy. Spasticity of the calf in children with cerebral palsy restricts full movement of the ankle during walking, which causes pain and forces the children to walk on their toes. Researchers want to know if the study medication, a natural toxin that works on nerves and causes muscles to relax, can limit spasticity and allow children to walk on their feet instead of their toes.

Who can participate?

Children and teens 2 to 17 years old with cerebral palsy who have muscle stiffness in one or both legs may be eligible to participate.

What is involved?

Participation in this research study could last between three to seven months. The study involves at least five study visits and up to three additional follow-up visits, depending on how participants respond to treatment. All visits will take place at Cincinnati Children’s Hospital Medical Center.

Eligible participants will be randomly assigned to receive either one of two doses of the study medication or a placebo (a substance that looks like the study medication but does not contain any medicine) for one treatment cycle. There is a two out of three (66 percent) chance of receiving the study medication. This study is double-blinded, which means that neither parents/guardians, the study doctor nor the study staff knows which study medication the participants received; however, this information is available to the study doctor in the event of an emergency.

Participants will receive their assigned injection in four different locations of the calf muscles in one or both legs (depending on their condition and the doctor’s decision). They will then have follow-up visits four and 12 weeks, with a phone call in between, after receiving their injection. Additional follow-up visits may be needed 16, 22 and 28 weeks post-injection (depending on the effects of the treatment on participants).

At the end of the study, participants may be asked to take part in a follow-up study in which all participants receive repeated treatments with the study medication. 

A detailed list of tests and procedures will be provided to those interested in knowing more about this study.  

What are the benefits?

Participants may or may not receive any direct medical benefit from participating in this study. The results of this study may provide new information that could benefit children with cerebral palsy in the future.

Will I get all the facts about the study?

Parents/guardians who are interested in having their children 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 parents/guardians to ensure all questions are answered. Study procedures will not begin until this form is signed and participants have given their signed assent.

Do participants receive pay, compensation or reimbursement?

Families will receive $65 for each completed clinic visit and $25 for the phone call involved in the study. All study procedures, tests and the study medication will be provided at no cost.  

Who should I contact for more information?

Stephanie Hotze

(513) 803-1897

Clinical Trials Office, MLC 7004

Cincinnati Children’s Hospital Medical Center

3333 Burnet Ave.

Cincinnati, OH45229-3039

stephanie.hotze@cchmc.org

Principal Investigator

Douglas Kinnett, MD

Principal Investigator

Division of Physical Medicine and Rehabilitation

Cincinnati Children’s Hospital Medical Center