Cerebral Palsy Research Study for Children and Teens
What is the purpose of this study?
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
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
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
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
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?
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?
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
What are the risks and discomforts of the study?
Participants may experience some risks or
discomforts during the study.
Though uncommon, there are potential serious
side effects associated with the study medication, including difficulty
swallowing or breathing.
More common side effects include:
Participants also may feel weak in injected
leg(s), which could cause them to be unable to walk properly or fall. This
effect does wear off.
may be additional unknown or unforeseen risks associated with study
participation. 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?
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?
Trials Office, MLC 7004
Children’s Hospital Medical Center
3333 Burnet Ave.
of Physical Medicine and Rehabilitation
Children’s Hospital Medical Center