Trial reportMuscle & nerve2016
Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity.
Trial report in Muscle & nerve, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01392300 (Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb), which is not on this map. Cited by 35 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effects of incobotulinumtoxinA in children and adolescents with spastic cerebral palsy: A systematic review of randomized controlled trials.PM & R : the journal of injury, function, and rehabilitation · 2026Pooled it
- Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials.BioMed research international · 2019Pooled it
- Efficacy and Safety of IncobotulinumtoxinA for Treatment of Sialorrhea: A Multicenter, Phase 3 Study in Japan.Movement disorders clinical practice · 2026Trial
- Sustained efficacy of incobotulinumtoxina repeated injections for upper-limb post-stroke spasticity: A post hoc analysis.Journal of rehabilitation medicine · 2021Trial
- IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.Advances in therapy · 2019Trial
- IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study.Journal of pediatric rehabilitation medicineTrial
- Evolution of goal setting and attainment over repeated cycles of botulinum toxin A for upper limb spasticity in real-life clinical practice: longitudinal analyses from the observational ULIS-III cohort study.Journal of rehabilitation medicine · 2026Observational
- Review
- Observational
- Spinal cord stimulation for concurrent improvement of consciousness and spasticity following severe traumatic brain injury: a case study.Frontiers in neuroscience · 2026Article
- Efficacy and Safety of IncobotulinumtoxinA in Older Patients with Upper Limb Spasticity: A Pooled Analysis.Geriatrics (Basel, Switzerland) · 2025Article
- Patient-Centred and Daily Life-Oriented Botulinum Toxin Treatment for Stroke Survivors with Upper Extremity Spasticity-Effects and Practical Aspects.Journal of clinical medicine · 2025Article
- Botulinum Toxin Treatment in Hereditary Spastic Paraplegia-A Comprehensive Review and Update.Toxins · 2025Review
- Observational
- Article
- Clinical neurophysiology in the treatment of movement disorders: IFCN handbook chapter.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2024Review
- Review
- The Role of Botulinum Toxin Type-A in Spasticity: Research Trends from a Bibliometric Analysis.Toxins · 2024Review
- Article
- Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults.Toxins · 2023Article
Corrections and comments
- Erratum issuedErratum.2016
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEfficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied.
methodsSubjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400 U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow, 200 U; flexed wrist, 150 U; clenched fist, 100 U). Doses for non-primary patterns were flexible within predefined ranges.
resultsAt week 4, incobotulinumtoxinA led to larger improvements in PTCP Ashworth scale (AS) scores than placebo [least-squares mean change ± standard error: -0.9 ± 0.06 (n = 171) vs. -0.5 ± 0.08 (n = 88); P < 0.001], and more subjects were PTCP AS responders (≥1-point improvement) with incobotulinumtoxinA (69.6%) than with placebo (37.5%; P < 0.001). Investigator's Global Impression of Change confirmed superiority of incobotulinumtoxinA vs. placebo (P = 0.003). IncobotulinumtoxinA was associated with functional improvements, as demonstrated in responder rates for Disability Assessment Scale principal target at week 4 (P = 0.007). Adverse events were mainly mild/moderate, and were reported by 22.4% (incobotulinumtoxinA) and 16.8% (placebo) of subjects.
conclusionsIncobotulinumtoxinA significantly improved upper-limb spasticity and associated disability, and was well-tolerated.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.