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Botulinum Toxin (BOTOX) for Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00060957
Recruitment Status : Completed
First Posted : May 19, 2003
Last Update Posted : September 26, 2016
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

May 16, 2003
May 19, 2003
September 26, 2016
July 1997
June 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00060957 on ClinicalTrials.gov Archive Site
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Botulinum Toxin (BOTOX) for Cerebral Palsy
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Cerebral Palsy
  • Muscle Spasticity
Drug: Botulinum toxin type A
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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June 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
1R01HD035750-01( U.S. NIH Grant/Contract )
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Ross M. Hays, M.D. Children's Hospital and Regional Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP