Botulinum Toxin (BOTOX) for Cerebral Palsy
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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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 1997 |
| Estimated Study Completion Date: | June 2002 |
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 |
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| United States, Washington | |
| Children's Hospital and Regional Medical Center | |
| Seattle, Washington, United States, 98105 | |
| Principal Investigator: | Ross M. Hays, M.D. | Children's Hospital and Regional Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00060957 History of Changes |
| Other Study ID Numbers: | 1R01HD35750-01 |
| Study First Received: | May 16, 2003 |
| Last Updated: | May 20, 2011 |
| 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:
|
Cerebral Palsy Muscle Spasticity Paralysis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations |
Neurologic Manifestations Signs and Symptoms Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013