HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Botulinum toxin type a neuromuscular blockade in the treatment of equinus foot deformity in cerebral palsy: a multicenter, open-label clinical trial.

AbstractBACKGROUND:
Focal spasticity of the gastrocnemius-soleus muscles causes equinus gait in children with cerebral palsy (CP). Botulinum toxin type A (BTX-A), a neuromuscular blocking agent, reduces muscle tone/overactivity in dystonia, stroke, and CP.
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.
AuthorsL 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
JournalPediatrics (Pediatrics) Vol. 108 Issue 5 Pg. 1062-71 (Nov 2001) ISSN: 1098-4275 [Electronic] United States
PMID11694682 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Neuromuscular Agents
  • Botulinum Toxins, Type A
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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: