Abstract
Background. 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1062-1071 |
| Number of pages | 10 |
| Journal | Pediatrics |
| Volume | 108 |
| Issue number | 5 |
| DOIs | |
| State | Published - Nov 12 2001 |
| Externally published | Yes |
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Keywords
- BTX-A
- Cerebral palsy
- Equinus foot deformity
- Neuromuscular blockade
- Pediatric patients
- Spasticity
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
Cite this
Botulinum toxin type A neuromuscular blockade in the treatment of equinus foot deformity in cerebral palsy : A multicenter, open-label clinical trial. / Koman, L. Andrew; Brashear, Allison; Rosenfeld, Samuel; Chambers, Henry; Russman, Barry; Rang, Mercer; Root, Leon; Ferrari, Eugenio; Garcia De Yebenes Prous, J.; Smith, Beth P.; Turkel, Catherine; Walcott, Jennifer M.; Molloy, Patricia T.
In: Pediatrics, Vol. 108, No. 5, 12.11.2001, p. 1062-1071.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Botulinum toxin type A neuromuscular blockade in the treatment of equinus foot deformity in cerebral palsy
T2 - A multicenter, open-label clinical trial
AU - Koman, L. Andrew
AU - Brashear, Allison
AU - Rosenfeld, Samuel
AU - Chambers, Henry
AU - Russman, Barry
AU - Rang, Mercer
AU - Root, Leon
AU - Ferrari, Eugenio
AU - Garcia De Yebenes Prous, J.
AU - Smith, Beth P.
AU - Turkel, Catherine
AU - Walcott, Jennifer M.
AU - Molloy, Patricia T.
PY - 2001/11/12
Y1 - 2001/11/12
N2 - Background. 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.
AB - Background. 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.
KW - BTX-A
KW - Cerebral palsy
KW - Equinus foot deformity
KW - Neuromuscular blockade
KW - Pediatric patients
KW - Spasticity
UR - http://www.scopus.com/inward/record.url?scp=17944376247&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=17944376247&partnerID=8YFLogxK
U2 - 10.1542/peds.108.5.1062
DO - 10.1542/peds.108.5.1062
M3 - Article
C2 - 11694682
AN - SCOPUS:17944376247
VL - 108
SP - 1062
EP - 1071
JO - Pediatrics
JF - Pediatrics
SN - 0031-4005
IS - 5
ER -