Trial reportJournal of neural transmission (Vienna, Austria : 1996)2013
Efficacy and safety of higher doses of botulinum toxin type A NT 201 free from complexing proteins in the upper and lower limb spasticity after stroke.
Trial report in Journal of neural transmission (Vienna, Austria : 1996), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- 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
- Trial
- The Role of Hemispheric Sensory Shifts: Impacts on Stretch Reflex and Motor Plasticity Post-Stroke.Medical hypotheses · 2025Article
- Long-Term Management of Post-Stroke Spasticity with Botulinum Toxin: A Retrospective Study.Toxins · 2024Article
- The Role of Botulinum Toxin Type-A in Spasticity: Research Trends from a Bibliometric Analysis.Toxins · 2024Review
- Botulinum Toxin-A High-Dosage Effect on Functional Outcome and Spasticity-Related Pain in Subjects with Stroke.Toxins · 2023Review
- High-definition transcranial direct current stimulation for upper extremity rehabilitation in moderate-to-severe ischemic stroke: a pilot study.Frontiers in human neuroscience · 2023Article
- Article
- European expert consensus on improving patient selection for the management of disabling spasticity with intrathecal baclofen and/or botulinum toxin type A.Journal of rehabilitation medicine · 2022Article
- Review
- Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA.Health and quality of life outcomes · 2020Article
- Review
- Safety Profile of High-Dose Botulinum Toxin Type A in Post-Stroke Spasticity Treatment.Clinical drug investigation · 2018Review
- Therapeutic efficacy and safety of various botulinum toxin A doses and concentrations in spastic foot after stroke: a randomized controlled trial.Neural regeneration research · 2017Article
- Benefits and Risks of Non-Approved Injection Regimens for Botulinum Toxins in Spasticity.Drugs · 2017Review
- Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study.Neurology · 2017Article
- Safety and efficacy of incobotulinumtoxinA as a potential treatment for poststroke spasticity.Neuropsychiatric disease and treatment · 2016Review
- High doses of onabotulinumtoxinA in post-stroke spasticity: a retrospective analysis.Journal of neural transmission (Vienna, Austria : 1996) · 2015Article
- Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders.Drug design, development and therapy · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Botulinum toxin type A (BTX-A) represents the gold standard therapy for focal spasticity after stroke, with low prevalence of complications, reversibility, and efficacy in reducing spastic hypertonia. Current guidelines suggest the employment of a dosage up to 600 units (U) of BTX-A to treat spasticity after stroke, to avoid important adverse effects and the development of antibodies against the neurotoxin. In recent years, NT 201, a new BTX-A free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity. In a prospective, non-randomized, open-label study, we studied the efficacy and safety of higher doses of BTX-A NT 201 (up to 840 U) in 25 consecutive patients with upper and lower limb spasticity after stroke, evaluated at 30 and 90 days after injections. Before and after the treatment, the grade of spasticity, the disability, and spasticity-related pain were extensively measured. After 30 days of follow-up, a great reduction of spasticity and pain with improvement of disability was observed. The effects were still present at 90 days of follow-up. No major adverse events were observed. Higher doses of BTX-A NT 201 appeared to be safe and efficacious in patients with upper and lower limb spasticity after stroke. However, further investigations are needed to determine its reproducibility in larger case series or randomized clinical trials and to observe the absence of antibodies against the neurotoxin also after repeated injections.
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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.