Trial reportStroke and vascular neurology2026
Loberamisal injection for the treatment of acute ischaemic stroke: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial.
Trial report in Stroke and vascular neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06429384 (Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial -- Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial), which is not on this map. Not yet cited in PubMed.
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Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial -- Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial
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11 authors.
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Abstract
BACKGROUND AND
aimsLoberamisal is a small-molecule agent that inhibits the nNOS-postsynaptic density protein 95 coupling and enhances α2-containing γ-aminobutyric acid type A receptor, which has been shown effective in animal studies. This trial aimed to investigate its safety and therapeutic efficacy in patients with acute ischaemic stroke (AIS) within 48 hours of symptom onset.
methodsPatients were randomly assigned in a 1:1:1:1 ratio to one of four groups: a low-dose loberamisal group (20 mg/dose), a medium-dose group (40 mg/dose), a high-dose group (60 mg/dose) or a placebo group. All patients received a continuous intravenous infusion treatment once a day for 10 days (60±10 min/dose). The primary efficacy outcome was the proportion of patients achieving an excellent functional outcome (a modified Rankin Scale score of 0-1 at 90 days). The primary safety outcome was the incidence of adverse events (AEs).
resultsA total of 240 patients were randomised, of whom 224 received study treatment from 4 June 2023 to 18 November 2023. The proportion of patients with excellent functional outcome was highest in the medium-dose group (76.7%, 46/60), followed by the high-dose group (70.0%, 42/60), the low-dose group (67.8%, 40/59) and the placebo group (60.7%, 37/61) (p=0.164). Regarding safety, 210 patients experienced at least one AE, with incidences of 80.0% (48/60), 88.3% (53/60) and 91.5% (54/59) in the high, medium and low-dose loberamisal groups, respectively, and 90.2% (55/61) in the placebo group (p=0.260).
conclusionsLoberamisal injection was well tolerated in patients with AIS within 48 hours of symptom onset in China. The efficacy and optimal dosage of loberamisal for AIS need prospective validation. TRIAL REGISTRATION NUMBER: ChiCTR2400081662, NCT06429384.
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