Abstract | BACKGROUND: OBJECTIVE: A prospective, open-label, multicenter clinical trial evaluated the long-term safety and efficacy of repeated intramuscular injections of BTX-A on equinus gait in CP children. METHODS: Nine centers enrolled 207 children. BTX-A injections (4 U/Kg) were given approximately every 3 months (maximum dose 200 U per treatment). Outcome measures included a Physician Rating Scale of gait, ankle range of motion measurements, and the incidence and profile of adverse events. RESULTS: One hundred fifty-five (75%) of 207 children completed at least 1 year with a total of 302 patient years of BTX-A treatment. The mean duration of BTX-A exposure was 1.46 years per patient. Dynamic gait pattern on the Physician Rating Scale improved in 46% of patients (86/185) at first follow-up. The response was maintained in 41% to 58% of patients for 2 years. Both gait pattern and ankle position improved at every visit. The most common treatment-related adverse events included increased stumbling, leg cramps, leg weakness, and calf atrophy in 1% to 11% of patients. No treatment-related serious adverse events were reported. Only 6% (7/117) of patients with pre- and postantibody samples had both detectable antibodies and a subsequent treatment failure. CONCLUSION: BTX-A proved both safe and effective in the chronic management of focal muscle spasticity in children with equinus gait.
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Authors | L A Koman, A Brashear, S Rosenfeld, H Chambers, B Russman, M Rang, L Root, E Ferrari, J Garcia de Yebenes Prous, B P Smith, C Turkel, J M Walcott, P T Molloy |
Journal | Pediatrics
(Pediatrics)
Vol. 108
Issue 5
Pg. 1062-71
(Nov 2001)
ISSN: 1098-4275 [Electronic] United States |
PMID | 11694682
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Neuromuscular Agents
- Botulinum Toxins, Type A
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Topics |
- Adolescent
- Botulinum Toxins, Type A
(therapeutic use)
- Cerebral Palsy
(complications)
- Equinus Deformity
(etiology, therapy)
- Female
- Gait
- Humans
- Male
- Neuromuscular Agents
(therapeutic use)
- Neuromuscular Blockade
(methods)
- Prospective Studies
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