PMID- 30484117
OWN - NLM
STAT- MEDLINE
DCOM- 20200115
LR  - 20200309
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 36
IP  - 1
DP  - 2019 Jan
TI  - IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity 
      Following Stroke: Results from the Open-Label Extension Period of a Phase 3 
      Study.
PG  - 187-199
LID - 10.1007/s12325-018-0833-7 [doi]
AB  - 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 < 0.0001 for all). Over 90% of subjects were assessed by the 
      investigator to be at least minimally improved (4 weeks post-injection) on the 
      GICS during each injection cycle; 61.0% in the 1st cycle, 58.2% in the 2nd cycle, 
      and 57.4% in the 3rd cycle were considered much improved or very much improved on 
      the GICS. Three percent of subjects (9/296) reported treatment-related AEs; the 
      most frequently reported were pain in the extremity (n = 2, 0.7%) and 
      constipation (n = 2, 0.7%). Serious AEs were reported by 22 subjects (7.4%); 
      however, none were considered treatment-related. 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.
FAU - Marciniak, Christina
AU  - Marciniak C
AD  - Department of Physical Medicine and Rehabilitation and Department of Neurology, 
      Northwestern University Feinberg School of Medicine, Shirley Ryan AbilityLab, 
      Chicago, IL, USA. cmarciniak@sralab.org.
FAU - Munin, Michael C
AU  - Munin MC
AD  - Department of Physical Medicine and Rehabilitation, University of Pittsburgh 
      School of Medicine, Pittsburgh, PA, USA.
FAU - Brashear, Allison
AU  - Brashear A
AD  - Department of Neurology, Wake Forest School of Medicine, Wake Forest Baptist 
      Medical Center, Winston Salem, NC, USA.
FAU - Rubin, Bruce S
AU  - Rubin BS
AD  - Design Neuroscience Center, Doral, FL, USA.
FAU - Patel, Atul T
AU  - Patel AT
AD  - Kansas City Bone & Joint Clinic, Overland Park, KS, USA.
FAU - Slawek, Jaroslaw
AU  - Slawek J
AD  - Department of Neurological-Psychiatric Nursing, Medical University of Gdansk, 
      Gdansk, Poland.
FAU - Hanschmann, Angelika
AU  - Hanschmann A
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Hiersemenzel, Reinhard
AU  - Hiersemenzel R
AD  - Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
FAU - Elovic, Elie P
AU  - Elovic EP
AD  - University of Nevada at Reno, Reno, NV, USA.
LA  - eng
SI  - figshare/10.6084/m9.figshare.7284806
SI  - ClinicalTrials.gov/NCT01392300
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181127
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (incobotulinumtoxinA)
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Botulinum Toxins, Type A/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscle Spasticity/*drug therapy/etiology
MH  - Neuromuscular Agents/*therapeutic use
MH  - Severity of Illness Index
MH  - Stroke/complications/*drug therapy
MH  - Treatment Outcome
MH  - Upper Extremity/physiopathology
MH  - Young Adult
PMC - PMC6318229
OTO - NOTNLM
OT  - IncobotulinumtoxinA
OT  - Neurology
OT  - Spasticity
OT  - Stroke
EDAT- 2018/11/30 06:00
MHDA- 2020/01/16 06:00
PMCR- 2018/11/27
CRDT- 2018/11/29 06:00
PHST- 2018/07/24 00:00 [received]
PHST- 2018/11/30 06:00 [pubmed]
PHST- 2020/01/16 06:00 [medline]
PHST- 2018/11/29 06:00 [entrez]
PHST- 2018/11/27 00:00 [pmc-release]
AID - 10.1007/s12325-018-0833-7 [pii]
AID - 833 [pii]
AID - 10.1007/s12325-018-0833-7 [doi]
PST - ppublish
SO  - Adv Ther. 2019 Jan;36(1):187-199. doi: 10.1007/s12325-018-0833-7. Epub 2018 Nov 
      27.