Byline: Christina Marciniak (1), Michael C. Munin (2), Allison Brashear (3), Bruce S. Rubin (4), Atul T. Patel (5), Jaroslaw Slawek (6), Angelika Hanschmann (7), Reinhard Hiersemenzel (7), Elie P. Elovic (8) Keywords: IncobotulinumtoxinA; Neurology; Spasticity; Stroke Abstract: Introduction The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods Adults 18--80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for forearm pronators (P Conclusions Repeated injections of incobotulinumtoxinA for the treatment of post-stroke upper-limb spasticity led to significant improvements in muscle tone and investigator's global impression of change. Treatment was well tolerated, with no serious treatment-related AEs. Funding Merz Pharmaceuticals GmbH. Author Affiliation: (1) 0000 0001 2299 3507, grid.16753.36, Department of Physical Medicine and Rehabilitation and Department of Neurology, Northwestern University Feinberg School of Medicine, Shirley Ryan AbilityLab, Chicago, IL, USA (2) 0000 0004 1936 9000, grid.21925.3d, Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA (3) 0000 0004 0459 1231, grid.412860.9, Department of Neurology, Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston Salem, NC, USA (4) Design Neuroscience Center, Doral, FL, USA (5) Kansas City Bone & Joint Clinic, Overland Park, KS, USA (6) 0000 0001 0531 3426, grid.11451.30, Department of Neurological-Psychiatric Nursing, Medical University of Gdansk, Gdansk, Poland (7) 0000 0004 0390 9404, grid.469959.e, Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany (8) 0000 0004 1936 914X, grid.266818.3, University of Nevada at Reno, Reno, NV, USA Article History: Registration Date: 02/11/2018 Received Date: 24/07/2018 Online Date: 27/11/2018 Article note: Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.7284806.