Botulinum Toxin (BOTOX) for Cerebral Palsy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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