- Design
- multicentre, double-blind, placebo-controlled phase 3 randomised trial at 32 hospitals
- Population
- 997 adults aged 18-80 with acute ischaemic stroke, NIHSS 7-20, within 48 hours of onset
- Primary outcome
- modified Rankin score 0-1 at 90 days
- Effect
- 69.7% versus 56.3%; risk difference 13.28% (95% CI 7.24 to 19.32); relative risk 1.24 (1.12-1.36)
LAIS randomised 998 adults with acute ischaemic stroke at 32 hospitals in China to intravenous loberamisal 40 mg daily for ten days or matching placebo, on top of standard care. Eligibility was an NIHSS of 7 to 20, no pre-stroke disability, and presentation within 48 hours of onset. Median age was 64, median NIHSS 8.
At 90 days, 350 of 502 patients (69.7%) given loberamisal had a modified Rankin score of 0 to 1 - full functional recovery - against 279 of 495 (56.3%) on placebo. The risk difference was 13.3 percentage points (95% CI 7.2 to 19.3), relative risk 1.24 (1.12 to 1.36). Serious adverse events were slightly fewer on the drug (8.6% versus 10.7%) and deaths were 1.2% versus 2.0%.
The reason to read this carefully rather than simply welcome it is the history of the field. Neuroprotection has produced a long series of trials that looked like this and then failed to replicate outside their original setting. This one is single-country, the strokes were moderate, the median NIHSS of 8 sits at the bottom of the eligible range, and a 48-hour window is far wider than the windows in which reperfusion works - which makes the size of the effect harder to explain mechanistically, not easier. The drug is not licensed or available outside trials. Nothing changes in a stroke unit this week; what changes is which trial you watch for.
- Do not alter acute stroke pathways - reperfusion timing remains the intervention with established benefit
- Note the population: NIHSS 7 to 20, no pre-stroke disability, within 48 hours - not the whole stroke take
- Expect the replication question to be raised in any discussion of this drug; a single-country phase 3 is where past neuroprotectants also stood
- Keep counselling families on rehabilitation intensity, which remains the modifiable factor in recovery
- Watch for multinational replication before treating this as a class that works
Why it matters
Neuroprotection after stroke has been a graveyard of positive early trials - a result this large demands a replication before it is believed, not because it is small but because it is big.
Don't overread it
One country, 32 sites, moderate strokes and no external replication - this establishes a hypothesis worth testing multinationally, not a treatment.
The statistics, in plain English
A 13.3 percentage point absolute difference means roughly eight patients treated for one extra person to reach full independence, which would be a very large effect for any stroke therapy other than reperfusion. The confidence interval, 7.2 to 19.3, excludes zero comfortably, so chance is an unlikely explanation within this trial. What a confidence interval cannot tell you is whether the result transports: the uncertainty that matters here is between-population, not within-trial, and no interval measures that.
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