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Shi Huang

Chinese medical scientists have shattered the brief window of time available to limit stroke damage, effectively shielding injured brain cells and dramatically improving the odds of a full recovery.
Brain cells start dying within minutes of a clot blocking an artery, leading to facial droop, affected speech and in severe cases, paralysis or death. Emergency treatments, such as clot-busting drugs or surgery, must be given within a maximum of six hours.
According to a study published by the top-tier Journal of the American Medical Association on September 10, clinical trials of the drug loberamisal found it was possible to expand the time available to 48 hours.
The large-scale multicentre phase 3 trial found that 70 per cent of patients who received loberamisal intravenously within two days of a stroke regained complete functional independence – an increase of 13 percentage points over standard care alone.
In just three months, they were able to resume their daily lives with no significant disability, according to the research team led by Wang Yongjun, one of China’s leading neurologists.
Wang, a co-responding author of the paper, is vice-president of Beijing Tiantan Hospital, affiliated with Capital Medical University, and director of the neurology centre.


“Among patients with acute ischaemic stroke treated within 48 hours of symptom onset, intravenous loberamisal, compared with placebo, resulted in a higher proportion of patients achieving complete functional recovery at 90 days,” the team wrote.
Nearly 12 million new cases occur worldwide each year, meaning that on average there is someone suffering a stroke every three seconds or less – roughly the time it takes to read this sentence.
Common treatments for stroke include intravenous thrombolytic therapy and endovascular thrombectomy. Yet, a considerable number of patients do not meet the indications for these therapies.
At the same time, because the damage caused by cerebral ischaemia and hypoxia can be persistent, even if the blood clot is quickly removed, the recovery of the nervous system remains difficult.
Loberamisal is a single-molecule multi-target neuroprotective drug that acts as a protective and reparative agent for brain cells, reducing their excitability and blocking neuroinflammation and oxidative stress.
After a stroke, it reduces oxygen consumption and inflammation in the brain, saving as many brain cells as possible that have been injured by ischaemia but have not yet died, thus reducing the effects of hemiplegia, aphasia and other symptoms.
Similar treatments have been developed in Canada, the United States and Japan but have failed in their trials.
The Chinese study involved 998 patients from 32 hospitals. All had experienced a moderate to moderately severe stroke within the previous 48 hours. Typical symptoms included severe hemiplegia, aphasia, visual field defects, or decreased consciousness.
Half of the participants were randomly assigned to receive 10 days of intravenous loberamisal therapy while the remainder received a placebo injection. Other treatments remained the same.
Ischaemic stroke patients everywhere will benefit if confirmatory studies corroborate these first tantalising results
Jeffrey Saver, neurologist
At Day 90 of the treatment, 350 of the 502 patients in the loberamisal group had achieved complete functional recovery to the extent that they could fully resume daily work and life activities.
Only 279 of the 495 people in the placebo group reached the same criterion, a difference of 13.4 per cent.
According to the paper, the types and frequencies of adverse events experienced by the two groups of patients in the clinical trial were similar. The researchers concluded that this showed the safety data was reassuring and the overall results were encouraging.
Neurologist Jeffrey Saver, associate editor of the journal, devoted his editorial to the Chinese findings in the same issue of the publication.
“For more than 70 years, randomised clinical trials have tested neuroprotective and neuroreparative therapies. Hundreds of promising agents were tested. Tens of thousands of patients enrolled. The result: failure over and over again. Until, perhaps, now,” he wrote.
“Ischaemic stroke patients everywhere will benefit if confirmatory studies corroborate these first tantalising results.”
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China

Large-scale clinical trial with nearly 1,000 patients from 32 hospitals delivers 13 per cent leap in recovery over standard care alone


Large-scale clinical trial with nearly 1,000 patients from 32 hospitals delivers 13 per cent leap in recovery over standard care alone.


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Chinese drug loberamisal extends stroke treatment window from 6 hours to 2 days

.css-1c6uqr6{color:inherit;font-weight:inherit;font-size:inherit;font-family:inherit;line-height:inherit;overflow-wrap:break-word;}Large-scale clinical trial with nearly 1,000 patients from 32 hospitals delivers 13 per cent leap in recovery over standard care alone

Large-scale clinical trial with nearly 1,000 patients from 32 hospitals delivers 13 per cent leap in recovery over standard care alone