Cerebral Palsy Clinical Trial
Official title:
Botulinum Toxin for Spasticity in Cerebral Palsy
This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | June 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Spastic diplegic cerebral palsy - Community or independent ambulators - Expressive communication skills at age 3 or above - Stable social environment - Reasonable proximity to the medical center - Physical therapy at least once per week - No other serious health problems that would interfere with the study Exclusion Criteria: - Other forms of cerebral palsy - Previous treatment with botulinum toxin - Musculoskeletal contractures greater than 15 degrees - Unstable social environment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital and Regional Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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