Trial reportBMC neurology2026
Effect of riluzole on cognitive and functional outcomes after severe traumatic brain injury: a randomized controlled trial.
Trial report in BMC neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGlutamate-mediated excitotoxicity is a key mechanism of secondary neuronal injury after severe traumatic brain injury (TBI). Riluzole, a sodium–glutamate antagonist with established safety in other neurologic disorders, has demonstrated neuroprotective effects in preclinical models, but clinical evidence in TBI remains limited.
methodsIn this single-center, randomized, double-blind, placebo-controlled trial, 160 adults with severe TBI (Glasgow Coma Scale ≤8) were assigned (1:1) to riluzole (50 mg twice on day 1, then 50 mg daily for 13 days) or placebo, alongside guideline-based care. The primary outcome was cognitive status measured by the Montreal Cognitive Assessment (MoCA) at day 28. Secondary outcomes included MoCA at day 14, Functional Independence Measure (FIM), daily GCS through day 14, Glasgow Outcome Scale–Extended (GOS-E) at day 28, radiographic progression, length of stay, and safety. Analyses followed the intention-to-treat principle.
resultsAt day 28, MoCA scores were not significantly different between groups (median 23 vs. 22; mean difference +1.0, 95% CI −0.1 to 2.1; P=0.069). Day-14 MoCA scores were also similar (P=0.249). No significant differences were observed in FIM, GOS-E, radiographic progression, or length of stay. Adverse event rates were comparable, and no drug-related serious adverse events occurred.
conclusionAdjunctive riluzole was safe but did not significantly improve short-term cognitive or functional outcomes after severe TBI. Further trials optimizing timing, dosing, and patient selection are warranted.
trial registrationIranian Registry of Clinical Trials (IRCT20241230064217N1), registered on March 8, 2025. Retrospectively registered.
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