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Botulinum Toxin (BOTOX) for Cerebral Palsy
This study is ongoing, but not recruiting participants.
First Received: May 16, 2003   Last Updated: June 23, 2005   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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

No publications provided

Study ID Numbers: 1R01HD35750-01
Study First Received: May 16, 2003
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00060957     History of Changes
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

Additional relevant MeSH terms:
Neuromuscular Manifestations
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Brain Damage, Chronic
Nervous System Diseases
Central Nervous System Diseases
Neuromuscular Agents
Brain Diseases
Pharmacologic Actions
Paralysis
Signs and Symptoms
Muscle Spasticity
Botulinum Toxins
Cerebral Palsy
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009