Trial reportStroke2017
Proof-of-Concept Randomized Trial of the Monoclonal Antibody GSK249320 Versus Placebo in Stroke Patients.
Trial report in Stroke, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01808261 (Study MAG104615, a Proof of Concept Study for GSK249320 Versus Placebo in Stroke Patients), which is not on this map. Cited by 19 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.
Study MAG104615, a Proof of Concept Study for GSK249320 Versus Placebo in Stroke Patients
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.
- Adjunctive cytoprotective therapies in acute ischemic stroke: a systematic review.Fluids and barriers of the CNS · 2021Pooled it
- Predictive Value of Upper Extremity Outcome Measures After Stroke-A Systematic Review and Metaregression Analysis.Frontiers in neurology · 2021Pooled it
- Soluble Nogo-Receptor-Fc decoy (AXER-204) in patients with chronic cervical spinal cord injury in the USA: a first-in-human and randomised clinical trial.The Lancet. Neurology · 2023Trial
- Review
- Review
- Immunotherapies for Ischemic Stroke Patients: Current Status and Future Directions.Medical sciences (Basel, Switzerland) · 2026Review
- System Xc-pathway as a potential regulatory target in neurological disorders.Frontiers in pharmacology · 2025Review
- A Scoping Review of Minimal Important Change and Minimal Detectable Change of the Fugl-Meyer Assessment Lower Extremity Scale in Patients with Stroke.Physical therapy research · 2025Review
- Domain-Specific Outcome Measures in Clinical Trials of Therapies Promoting Stroke Recovery: A Suggested Blueprint.Stroke · 2023Review
- Advances in Antibody-Based Therapeutics for Cerebral Ischemia.Pharmaceutics · 2022Review
- Nogo-A receptor internalization by cyclic adenosine monophosphate in overcoming axonal growth inhibitors after stroke.Neural regeneration research · 2022Article
- Review
- Siglec-15 as an Emerging Target for Next-generation Cancer Immunotherapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Review
- Monoclonal antibody as an emerging therapy for acute ischemic stroke.International journal of physiology, pathophysiology and pharmacology · 2020Review
- Pharmacological Enhancement of Stroke Recovery.Current neurology and neuroscience reports · 2019Review
- Review
- Rewiring the connectome: Evidence and effects.Neuroscience and biobehavioral reviews · 2018Review
- Treatments to Promote Neural Repair after Stroke.Journal of stroke · 2018Review
- Enhancing Plasticity of the Central Nervous System: Drugs, Stem Cell Therapy, and Neuro-Implants.Neural plasticity · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
Abstract
background and purposeOne class of poststroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein. The purpose of the current study was to extend preclinical and clinical findings of GSK249320, a humanized monoclonal antibody to myelin-associated glycoprotein with disabled Fc region, to explore effects on motor outcomes poststroke.
methodsIn this phase IIb double-blind, randomized, placebo-controlled study, patients at 30 centers with ischemic stroke 24 to 72 hours prior and gait deficits were randomized to 2 IV infusions of GSK249320 or placebo. Primary outcome measure was change in gait velocity from baseline to day 90.
resultsA total of 134 subjects were randomized between May 2013 and July 2014. The 2 groups were overall well matched at baseline. The study was stopped at the prespecified interim analysis because the treatment difference met the predefined futility criteria cutoff; change in gait velocity to day 90 was 0.55±0.46 (mean±SD) in the GSK249320 group and 0.56±0.50 for placebo. Secondary end points including upper extremity function were concordant. The 2 IV infusions of GSK249320 were well tolerated. No neutralizing antibodies to GSK249320 were detected.
conclusionsGSK249320, within 72 hours of stroke, demonstrated no improvement on gait velocity compared with placebo. Possible reasons include challenges translating findings into humans and no direct evidence that the therapy reached the biological target. The antibody was well tolerated and showed low immunogenicity, findings potentially useful to future studies aiming to use a monoclonal antibody to modify activity in specific biological pathways to improve recovery from stroke. CLINICAL
trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01808261.
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.