Loberamisal for Acute Ischemic Stroke: The LAIS Randomized Clinical Trial.
Shuya Li, Baoyu Feng, Dandan He et al.
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In 30 seconds
The LAIS trial was a multicenter, double-blind, randomized, placebo-controlled phase 3 study at 32 hospitals in China. It enrolled adults aged 18 to 80 years with acute ischemic stroke, treated within 48 hours, and compared 10 days of intravenous loberamisal plus standard care with placebo plus standard care. Among 997 participants in the primary analysis, 69.7% receiving loberamisal and 56.3% receiving placebo achieved an mRS score of 0 to 1 at 90 days (relative risk, 1.24; 95% CI, 1.12-1.36). Adverse-event rates were similar between groups.
Key findings
- At 90 days, mRS scores of 0 to 1 occurred in 69.7% with loberamisal versus 56.3% with placebo (relative risk, 1.24; 95% CI, 1.12-1.36).
- Adverse events occurred in 87.8% of the loberamisal group and 88.7% of the placebo group.
- Serious adverse events occurred in 8.6% with loberamisal and 10.7% with placebo; all-cause mortality was 1.2% and 2.0%, respectively.
Why it matters
The trial reports improved 90-day functional outcomes with loberamisal, an investigational therapy targeting two pathways, when added to standard stroke care. The result addresses the limited availability of effective neuroprotective or neuroreparative treatments for acute ischemic stroke. Similar overall adverse-event rates are reassuring within the studied population, while confirmation and evidence in broader patient groups remain necessary.
What to keep in mind
The trial enrolled a selected population: adults aged 18 to 80 years with baseline NIHSS scores of 7 to 20 and no prestroke disability, treated within 48 hours. The authors state that further studies are needed to validate the findings and assess broader applicability.