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Botulinum Toxin (BOTOX) for Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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)

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Muscle Spasticity Drug: Botulinum toxin type A Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Botulinum Toxin for Spasticity in Cerebral Palsy
Study Start Date : July 1997
Actual Primary Completion Date : June 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060957

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United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
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

Layout table for additonal information Identifier: NCT00060957    
Other Study ID Numbers: 1R01HD035750-01 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2003    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: May 2011
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Cerebral Palsy
Botulinum toxin
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents