Botulinum Toxin (BOTOX) for Cerebral Palsy
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Palsy; Muscle Spasticity
Intervention: Botulinum toxin type A (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Ross M. Hays, M.D., Principal Investigator, Affiliation: Children's Hospital and Regional Medical Center
Summary
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.
Clinical Details
Official title: Botulinum Toxin for Spasticity in Cerebral Palsy
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed description:
This trial will test the effectiveness of BTX injections versus placebo to reduce
plantar-flexor spasticity and improve function and mobility in children with spastic
diplegia, a common form of cerebral palsy. The study will evaluate the effects of the
treatment across five domains that relate to disability: pathophysiology, impairment,
functional limitation, disability, and societal limitation.
Forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups.
Group A will receive BTX. Group B will receive a placebo injection. Participants will be
assessed at the beginning of the trial and at Weeks 3, 8, 12, and 24. Assessments include
quantitative electromyographic kinesiology measurements, electromechanical measurement of
joint torque across the ankle joint using the Spasticity Measurement System, Gross Motor
Function Measure, physical exam parameters, energy expenditure using the Energy Cost Index,
kinematic gait analysis, and the Canadian Occupational Performance Measure.
Participants are followed for a total of 6 months. Participants initially randomized to
Group B will have the opportunity for BTX treatment after 24 weeks.
Eligibility
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Children's Hospital and Regional Medical Center, Seattle, Washington 98105, United States
Additional Information
Starting date: July 1997
Ending date: June 2002
Last updated: June 23, 2005
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