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Botulinum Toxin (BOTOX) for Cerebral Palsy

This study is ongoing, but not recruiting participants.

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00060957
  Purpose

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 Intervention Phase
Cerebral Palsy
Muscle Spasticity
Drug: Botulinum toxin type A
Phase II

MedlinePlus related topics:   Botox    Cerebral Palsy    Paralysis   

Drug Information available for:   Clostridium botulinum toxin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Botulinum Toxin for Spasticity in Cerebral Palsy

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   40
Study Start Date:   July 1997
Estimated Study Completion Date:   June 2002

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
Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060957

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

Sponsors and Collaborators

Investigators
Principal Investigator:     Ross M. Hays, M.D.     Children's Hospital and Regional Medical Center    
  More Information


Study ID Numbers:   1R01HD35750-01
First Received:   May 16, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00060957
Health Authority:   United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Cerebral Palsy  
Spasticity  
Botulinum toxin  
BOTOX  

Study placed in the following topic categories:
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases
Paralysis
Signs and Symptoms
Muscle Spasticity
Botulinum Toxins
Cerebral Palsy
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Brain Injuries
Botulinum Toxin Type A

Additional relevant MeSH terms:
Neuromuscular Manifestations
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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