Trial reportNeurology2017
Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension.
Trial report in Neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 41 papers, 3 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.
A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury
Who cites it
41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.
- Systematic Review and Meta-Analysis of Secondary Treatment Failure and Immunogenicity With Botulinum Neurotoxin A in Multiple Indications.European journal of neurology · 2025Pooled it
- AbobotulinumtoxinA Doses in Upper and Lower Limb Spasticity: A Systematic Literature Review.Toxins · 2022Pooled it
- Pooled it
- The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury.PM & R : the journal of injury, function, and rehabilitation · 2021Trial
- Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial.PM & R : the journal of injury, function, and rehabilitation · 2020Trial
- Composite active range of motion (CXClinical rehabilitation · 2020Trial
- Trial
- Botulinum Toxin Type A Improves Function According to Goal Attainment in Adults with Poststroke Lower Limb Spasticity in Real Life Practice.European neurology · 2019Trial
- Identification of spastic muscles involved in abnormal joint posture in patients with upper motor neuron syndrome: a narrative review.Journal of rehabilitation medicine · 2026Review
- Quality of Life Assessment Using the Leg Activity Measure in Ambulatory Individuals With Leg Spasticity: Findings From a Longitudinal, Observational Study Evaluating the Effectiveness of AbobotulinumtoxinA in Routine Practice.Archives of rehabilitation research and clinical translation · 2026Article
- Article
- Review
- Real-world use of botulinum toxin-A for post-stroke spasticity in the Netherlands: a retrospective claims study.Journal of rehabilitation medicine · 2026Observational
- Reliability of the Five Step Assessment and Its Coefficients of Impairment in Spastic Paresis.Archives of rehabilitation research and clinical translation · 2025Article
- Muscle selection and dosing in patients undergoing treatment with abobotulinumtoxinA for lower limb spasticity in real-world practice.Journal of rehabilitation medicine · 2025Observational
- Clinical Outcome Assessments for Spasticity: Review, Critique, and Recommendations.Movement disorders : official journal of the Movement Disorder Society · 2025Article
- Clinical neurophysiology in the treatment of movement disorders: IFCN handbook chapter.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2024Review
- Post-stroke spasticity: follow-up and functional implications of chronic long-term treatment with botulinum toxin.European journal of physical and rehabilitation medicine · 2024Observational
- Improving Spasticity by Using Botulin Toxin: An Overview Focusing on Combined Approaches.Brain sciences · 2024Review
- The Role of Botulinum Toxin Type-A in Spasticity: Research Trends from a Bibliometric Analysis.Toxins · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo demonstrate single abobotulinumtoxinA injection efficacy in lower limb vs placebo for adults with chronic hemiparesis and assess long-term safety and efficacy of repeated injections.
methodsIn a multicenter, double-blind, randomized, placebo-controlled, single-cycle study followed by a 1-year open-label, multiple-cycle extension, adults ≥6 months after stroke/brain injury received one lower limb injection (abobotulinumtoxinA 1,000 U, abobotulinumtoxinA 1,500 U, placebo) followed by ≤4 open-label cycles (1,000, 1,500 U) at ≥12-week intervals. Efficacy measures included Modified Ashworth Scale (MAS) in gastrocnemius-soleus complex (GSC; double-blind primary endpoint), physician global assessment (PGA), and comfortable barefoot walking speed. Safety was the open-label primary endpoint.
resultsAfter a single injection, mean (95% confidence interval) MAS GSC changes from baseline at week 4 (double-blind, n = 381) were as follows: -0.5 (-0.7 to -0.4) (placebo, n = 128), -0.6 (-0.8 to -0.5) (abobotulinumtoxinA 1,000 U, n = 125;
conclusionsIn chronic hemiparesis, single abobotulinumtoxinA (Dysport Ipsen) administration reduced muscle tone. Repeated administration over a year was well-tolerated and improved walking speed and likelihood of achieving community ambulation. CLINICALTRIALGOV IDENTIFIERS: NCT01249404, NCT01251367. CLASSIFICATION OF EVIDENCE: The double-blind phase of this study provides Class I evidence that for adults with chronic spastic hemiparesis, a single abobotulinumtoxinA injection reduces lower extremity muscle tone.
Indexed as
Identifiers
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.