Article

Poststroke distal lower limb spasticity impairs mobility, limiting
activities of daily living and requiring additional caregiver time. OBJECTIVE: To
evaluate the efficacy, safety, and sustained benefit of onabotulinumtoxinA in
adults with poststroke lower limb spasticity (PSLLS). DESIGN: A multicenter,
randomized, double-blind, phase 3, placebo-controlled trial (NCT01575054).
SETTING: Sixty study centers across North America, Europe, Russia, the United
Kingdom, and South Korea. PATIENTS: Adult patients (18-65 years of age) with
PSLLS (Modified Ashworth Scale [MAS] >/=3) of the ankle plantar flexors and the
most recent stroke >/=3 months before study enrollment. INTERVENTIONS: During the
open-label phase, patients received </=3 onabotulinumtoxinA treatments (</=400 U)
or placebo at approximately 12-week intervals. Treatments were into the ankle
plantar flexors (onabotulinumtoxinA 300 U into ankle plantar flexors; </=100 U,
optional lower limb muscles). MAIN OUTCOME MEASUREMENTS: The double-blind primary
endpoint was MAS change from baseline (average score at weeks 4 and 6). Secondary
measures included physician-assessed Clinical Global Impression of Change (CGI),
MAS change from baseline in optional muscles, Goal Attainment Scale (GAS), and
pain scale. RESULTS: Of 468 patients enrolled, 450 (96%) completed the
double-blind phase and 413 (88%) completed the study. Small improvements in MAS
observed with onabotulinumtoxinA during the double-blind phase
(onabotulinumtoxinA, -0.8; placebo, -0.6, P = .01) were further enhanced with
additional treatments through week 6 of the third open-label treatment cycle
(onabotulinumtoxinA/onabotulinumtoxinA, -1.2; placebo/onabotulinumtoxinA, -1.4).
Small improvements in CGI observed during the double-blind phase
(onabotulinumtoxinA, 0.9; placebo, 0.7, P = .01) were also further enhanced
through week 6 of the third open-label treatment cycle
(onabotulinumtoxinA/onabotulinumtoxinA, 1.6; placebo/onabotulinumtoxinA, 1.6).
Physician- and patient-assessed GAS scores improved with each subsequent
treatment. No new safety signals emerged. CONCLUSIONS: OnabotulinumtoxinA
significantly improved ankle MAS, CGI, and GAS scores compared with placebo;
improvements were consistent and increased with repeated treatments of
onabotulinumtoxinA over 1 year in patients with PSLLS. LEVEL OF EVIDENCE: I.
CI - Copyright (c) 2018 American Academy of Physical Medicine and Rehabilitation.
Published by Elsevier Inc. All rights reserved.

Langue : ANGLAIS