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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00060957
Other study ID # 1R01HD035750-01
Secondary ID
Status Completed
Phase Phase 2
First received May 16, 2003
Last updated September 23, 2016
Start date July 1997

Study information

Verified date May 2011
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date June 2002
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Botulinum toxin type A


Locations

Country Name City State
United States Children's Hospital and Regional Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

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