Jörg Wissel1, Vaidyanathan Ganapathy2, Anthony B Ward3, Jörgen Borg4, Per Ertzgaard5, Christoph Herrmann6, Anders Haggstrom7, Mohamed Sakel8, Julia Ma9, Rozalina Dimitrova9, Antony Fulford-Smith10, Patrick Gillard11. 1. Neurological Rehabilitation, Department of Neurology, Vivantes Klinikum Spandau, Berlin, Germany. 2. Health Economics & Outcomes Research, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA. 3. North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke on Trent, United Kingdom. 4. Department of Clinical Sciences, Karolinska Institute and Rehabilitation Medicine, Danderyd Hospital, Stockholm, Sweden. 5. Department of Rehabilitation Medicine and Department of Medicine and Health Sciences, Linköping University, Linköping, Sweden. 6. Department of Neurological Rehabilitation and Early Rehabilitation, Asklepios-Kliniken Schildautal, Seesen, Germany. 7. Department of Rehabilitation Medicine, Orebro University Hospital, Orebro, Sweden. 8. East Kent University Hospital NHS, Canterbury, Kent, United Kingdom. 9. Allergan Plc, Irvine, California, USA. 10. Allergan Holdings Ltd., Marlow International, The Parkway, Marlow, Buckinghamshire, United Kingdom. 11. Allergan Plc, Irvine, California, USA. Electronic address: Gillard_Patrick@allergan.com.
Abstract
CONTEXT: Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life. OBJECTIVES: To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX(®) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial. METHODS:Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks. Assessments included change from baseline on the 11-point pain numeric rating scale, proportion of patients with baseline pain ≥4 achieving ≥30% and ≥50% improvement in pain, and pain interference with work at Week 12, end of double-blind treatment, and Week 52. RESULTS: At baseline, most patients (74.3%) experienced pain and 47.4% had pain ≥4 (pain subgroup). Mean pain reduction from baseline at Week 12 was significantly greater with onabotulinumtoxinA + SC (-0.77, 95% CI -1.14 to -0.40) than placebo + SC (-0.13, 95% CI -0.51 to 0.24; P < 0.05). Higher proportions of patients in the pain subgroup achieved ≥30% and ≥50% reductions in pain at Week 12 with onabotulinumtoxinA + SC (53.7% and 37.0%, respectively) compared with placebo (28.8% and 18.6%, respectively; P < 0.05). Reductions in pain were sustained through Week 52. Compared with placebo + SC, onabotulinumtoxinA consistently reduced pain interference with work. CONCLUSION: This is the first randomized, placebo-controlled trial demonstrating statistically significant and clinically meaningful reductions in pain and pain interference with work with onabotulinumtoxinA in patients with PSS.
RCT Entities:
CONTEXT: Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life. OBJECTIVES: To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX(®) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial. METHODS:Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks. Assessments included change from baseline on the 11-point pain numeric rating scale, proportion of patients with baseline pain ≥4 achieving ≥30% and ≥50% improvement in pain, and pain interference with work at Week 12, end of double-blind treatment, and Week 52. RESULTS: At baseline, most patients (74.3%) experienced pain and 47.4% had pain ≥4 (pain subgroup). Mean pain reduction from baseline at Week 12 was significantly greater with onabotulinumtoxinA + SC (-0.77, 95% CI -1.14 to -0.40) than placebo + SC (-0.13, 95% CI -0.51 to 0.24; P < 0.05). Higher proportions of patients in the pain subgroup achieved ≥30% and ≥50% reductions in pain at Week 12 with onabotulinumtoxinA + SC (53.7% and 37.0%, respectively) compared with placebo (28.8% and 18.6%, respectively; P < 0.05). Reductions in pain were sustained through Week 52. Compared with placebo + SC, onabotulinumtoxinA consistently reduced pain interference with work. CONCLUSION: This is the first randomized, placebo-controlled trial demonstrating statistically significant and clinically meaningful reductions in pain and pain interference with work with onabotulinumtoxinA in patients with PSS.
Authors: Alyson R Plecash; Amokrane Chebini; Alvin Ip; Joshua J Lai; Andrew A Mattar; Jason Randhawa; Thalia S Field Journal: Curr Neurol Neurosci Rep Date: 2019-11-13 Impact factor: 5.081
Authors: Rami Burstein; Andrew M Blumenfeld; Stephen D Silberstein; Aubrey Manack Adams; Mitchell F Brin Journal: Headache Date: 2020-06-30 Impact factor: 5.887
Authors: Michael Creamer; Geoffrey Cloud; Peter Kossmehl; Michael Yochelson; Gerard E Francisco; Anthony B Ward; Jörg Wissel; Mauro Zampolini; Abdallah Abouihia; Alessandra Calabrese; Leopold Saltuari Journal: Stroke Date: 2018-09 Impact factor: 7.914
Authors: Carlo Trompetto; Lucio Marinelli; Laura Mori; Luca Puce; Chiara Avanti; Elena Saretti; Giulia Biasotti; Roberta Amella; Filippo Cotellessa; Domenico A Restivo; Antonio Currà Journal: Toxins (Basel) Date: 2022-01-05 Impact factor: 4.546
Authors: Jörg Wissel; Alexandre Camões-Barbosa; Georg Comes; Michael Althaus; Astrid Scheschonka; David M Simpson Journal: Toxins (Basel) Date: 2021-12-11 Impact factor: 4.546