At the beginning of their randomized, double-blind trial, the experts had set out to determine whether NA-1 was safe. They then focused their attention on injections of NA-1, and how these injections affected the number and volume of brain legions in stroke patients after surgery.
During the study, the researchers administered 185 patients who had just undergone surgery with either an intravenous infusion of NA-1 or a saline control - 92 of them received the NA-1 drug, while 93 participants were given the placebo. Throughout the following three days, the team performed MRIs on the patients to examine the degree of stroke legions present. To determine the results, the participants were followed-up 30 days later.
They wrote that NA-1 is effective and harmless for humans to use, in spite of two unfavorable occurrences where some of the participants were found to have transient low blood pressure caused by the new medication.
The authors also discovered that NA-1 was capable of lowering brain tissue impairment in the study participants. The patients who received the medication were found to have considerably fewer lesions than those who had been given the saline control. However, lesion volume was similar in the two groups.
Professor Michael Hill, lead author of the study, explained:
"Safe drugs to provide neuroprotection - defined as salvage of brain tissue by enhancing its resilience to the restricted blood flow that patients experience during these procedures - is a major unmet need in stroke treatment, and translation from animal studies to humans has been markedly unsuccessful so far.
Our research, which builds on existing animal studies, suggests that intravenous infusion of NA-1 reduces tissue damage in patients who suffer a small stroke after an operation to repair a brain aneurysm, and further research is now needed to investigate the efficacy of neuroprotection in larger clinical trials."
A successful neuroprotective agent is useful in nations that lack medical resourcesIn an associated statement, Dr Markku Kaste, from the Helsinki University Central Hospital in Finland, emphasizes the significance of a successful neuroprotective agent, especially for countries that are in short supply of medical resources.
"Because of limited resources in many low-income and middle-income countries, most patients with stroke will not have access to stroke unit care, although such care reduces mortality and chronic institutional care. This holds true even more for thrombolysis in ischaemic stroke. Therefore, this underlines the need for safe and effective neuroprotective drugs that can be given at a low service level.
However, such drugs should first be assessed in large, well designed and well executed randomised placebo-controlled double-blind clinical trials. Only after such trials will we know whether NA-1 - or one of the other drugs which have shown comparable effects - is the long-awaited holy grail for the treatment of patients with ischaemic stroke. The door is now reopening for new neuroprotection trials in stroke."
Written by Christine Kearney