Loberamisal for Acute Ischemic Stroke The LAIS Randomized Clinical Trial

 So you didn't followup on this earlier research and create protocols on its' use? Good to know you'll be fired soon for incompetence!

• loberamisal (2 posts to November 2025)

Loberamisal for Acute Ischemic Stroke: The LAIS Randomized Clinical Trial

1. Shuya Li, MD^1,2,3; Baoyu Feng, PhD²; Dandan He, PhD^2,4
2. et al

1. Author Affiliations 
2. Article Information

 

 

Question

  Does intravenous loberamisal administration achieve full functional outcomes in patients with acute ischemic stroke? 

Findings

  In this randomized clinical trial involving 998 patients treated within 48 hours of ischemic stroke onset, 69.7% with loberamisal vs 56.3% with placebo achieved full functional (modified Rankin Scale score, 0-1) outcome at 90 days, resulting in a statistically significant difference. 

Meaning

  Among patients with acute ischemic stroke within 48 hours of symptom onset, loberamisal, compared with placebo, resulted in a greater likelihood of full functional outcome at 90 days. 

Abstract

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 Loberamisal Treatment for Acute Ischemic Stroke and Functional Outcomes

Visual Abstract.

Importance  Effective neuroprotective and neuroreparative therapies for acute ischemic stroke remain limited. Loberamisal is a small-molecule compound that dually targets the postsynaptic density 95 (PSD-95) pathway and α2 γ-aminobutyric acid type α (α2-GABA_A) receptor.

Objective  To evaluate the efficacy and safety of intravenous loberamisal for improving functional outcomes in patients with acute ischemic stroke.

Design, Setting, and Participants  The Loberamisal for Acute Ischemic Stroke (LAIS) trial was a multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial conducted at 32 hospitals in China. Adults aged 18 to 80 years with acute ischemic stroke, a baseline National Institutes of Health Stroke Scale score of 7 to 20, and no prestroke disability (modified Rankin Scale score, ≤1) who presented within 48 hours of symptom onset were enrolled between July 24, 2024, and December 7, 2024, with final follow-up on April 8, 2025.

Interventions  Participants were randomly assigned (1:1) to receive intravenous loberamisal (40 mg) or matching placebo once daily for 10 consecutive days, in addition to standard stroke care.

Main Outcomes and Measures  The primary outcome was achieving a full functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 1. Safety outcomes included adverse events, serious adverse events, and mortality.

Results  Among 998 randomized participants, 997 received at least 1 dose of the study drug and were included in the primary analysis (502 in the loberamisal group and 495 in the placebo group). The median age was 64 years (IQR, 57-71), 336 participants (33.7%) were women, and the median baseline NIHSS score was 8 (IQR, 7-9). At 90 days, 350 participants (69.7%) in the loberamisal group achieved an mRS score of 0 to 1 compared with 279 (56.3%) in the placebo group (relative risk, 1.24; 95% CI, 1.12-1.36; risk difference, 13.28%; 95% CI, 7.24%-19.32%). Adverse events occurred in 441 participants (87.8%) in the loberamisal group and 439 (88.7%) in the placebo group. Serious adverse events occurred in 43 participants (8.6%) in the loberamisal group and 53 (10.7%) in the placebo group. All-cause mortality occurred in 6 participants (1.2%) in the loberamisal group and 10 (2.0%) in the placebo group.

Conclusions and Relevance  Among patients with acute ischemic stroke treated within 48 hours of symptom onset, intravenous loberamisal, compared with placebo, resulted in a higher proportion of patients achieving full functional outcomes at 90 days. Further studies are needed to validate these findings and establish whether the benefits could extend to a broader patient population.

Trial Registration  ClinicalTrials.gov Identifier: NCT06517173