OnabotulinumtoxinA for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial. Issue 7 (9th January 2018)

• Record Type: Journal Article
• Authors: Wein, Theodore; Esquenazi, Alberto; Jost, Wolfgang H.; Ward, Anthony B.; Pan, Grace; Dimitrova, Rozalina
• Is Part Of: PM&R. Volume 10:Issue 7(2018)
• Page Start: 693
• Page End: 703
• Publication Date: 2018-01-09
• Subjects: Medical rehabilitation -- Periodicals; Physical therapy -- Periodicals; Physical Therapy Modalities -- Periodicals; 615.5
• DOI: 10.1016/j.pmrj.2017.12.006
• Languages: English
• ISSNs: 1934-1482

Abstract

Abstract: Background: 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