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| 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 |
| 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:
Exclusion Criteria:
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
| 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 |
|
Cerebral Palsy Spasticity Botulinum toxin BOTOX |
|
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 |