A prospective, multicentre, randomized, double-blind, placebo-controlled trial of onabotulinumtoxinA to treat plantarflexor/invertor overactivity after stroke.
OBJECTIVE
To examine the safety and efficacy of onabotulinumtoxinA (Botox) for plantarflexor overactivity following stroke.


METHODS
Double-blind randomized controlled trial, open-label extension phase.


METHODS
Neurology rehabilitation facilities.


METHODS
Eighty-five subjects with lower limb hypertonia received 200 U (n = 28) or 300 U (n = 28) of onabotulinumtoxinA or saline (n = 29) injection.


METHODS
Plantarflexor Ashworth scores at 12 weeks post injection and adverse events. Secondary measures: self-reported spasm frequency and pain, physician rating of hypertonia severity, gait quality and active dorsiflexion.


RESULTS
Differences were not seen between onabotulinumtoxinA groups; hence data were pooled. Incidence of adverse events was not different between groups (P = 0.61). Reduction in hypertonia was not different between groups at 12 weeks (P = 0.53); however for subjects with Ashworth scores of >3 at baseline, 14/31 in the onabotulinumtoxinA group demonstrated a reduction of >1 grade versus 1/17 receiving placebo injection (P = 0.01). Overall, onabotulinumtoxinA-injected subjects demonstrated significantly greater improvement in spasm frequency (22/54 versus 4/29, P = 0.01), pain reduction (8/54 versus 1/29, P = 0.02), active dorsiflexion (8/54 versus 1/29 P = 0.03) and gait quality (17/54 versus 6/29, P = 0.02) than controls. In the open-label phase, a second onabotulinumtoxinA injection was associated with greater hypertonia reduction (P = 0.005) and gait quality (P = 0.002) compared with single injection.


CONCLUSIONS
OnabotulinumtoxinA injection for ankle flexor overactivity after stroke was safe and well tolerated but did not alter local spasticity at 12 weeks; it did reduce spasms and improve gait quality. There were no detectable differences between higher and lower doses. A second injection may be associated with greater change.
Department of Neurology, Royal Perth Hospital, Western Australia, Australia.
John Walter
JW
Dunne
Jean-Michel
JM
Gracies
Michael
M
Hayes
Brian
B
Zeman
Barbara Jennifer
BJ
Singer
D001315:Australia; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D020233:Gait Disorders, Neurologic / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D009122:Muscle Hypertonia / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D020521:Stroke / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A