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Botulinum Toxin (BOTOX) for Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00060957
First received: May 16, 2003
Last updated: September 23, 2016
Last verified: May 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Ross M. Hays, M.D. Children's Hospital and Regional Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00060957     History of Changes
Other Study ID Numbers: 1R01HD035750-01 
Study First Received: May 16, 2003
Last Updated: September 23, 2016
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:
Paralysis
Cerebral Palsy
Muscle Spasticity
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, Type A
incobotulinumtoxinA
abobotulinumtoxinA
onabotulinumtoxinA
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on December 07, 2016