The University of North Carolina School of Medicine is seeking participants for a research study on the treatment of gait abnormalities in Cerebral Palsy.
The purpose of this research study is to investigate the safety and effectiveness of shots given in the calf muscles of the affected leg(s) of a drug called BOTOX?. This drug is being investigated as a treatment for calf muscle tightness that occurs in some cerebral palsy patients.
In this study BOTOX? will be compared to a placebo.Therefore, patients wil be randomly assigned to receive either BOTOX? or placebo by a method similar to tossing a coin. All subjects will stand an equal chance to receive BOTOX? or the placebo.
This study is open to children with cerebral palsy who meet the following criteria:
* 2-7 Years of age
* Cooperative with medical staff and therapists
* Hemiplegic or diplegic
* Walk independently with or without assistive devices
* Have no other severe medical problems
* Walk with equinus foot on the affected leg(s)
* If taking antispasticity drugs, be on stable doses for at least 3 months
PARTICIPATION REQUIREMENTS
* Up to five (5) visits to the University of North Carolina School of Medicine so that the doctor can examine you
* Participation in the research study will last for approximately 16 weeks
* Have blood drawn at two (2) visits
* Have two injections in the calf
At the end of the 16 week trial, BOTOX? will be available to all subjects at no charge. Compensation for your time and travel expenses will be provided
This study is approved by the Institutional Review Board (IRB) of the University of North Carolina School of Medicine, and is being conducted by Joshua Alexander,MD, FAAP, FAAPMR
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