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Clinical trials for stroke drugs to enhance time window for intervention: Dr N K Venkataramana

Nandita Vijay, Bengaluru
Friday, October 8, 2021, 08:00 Hrs  [IST]

All the clinical trials of newer drugs for stroke will focus on minimising brain damage and enhance recovery. Stroke therapeutics is evolving and therefore early intervention is the key especially in those with poor blood supply before the brain loss tissue, said Dr N K Venkataramana, founder and chairman, Brains Hospitals.

Brain stroke is a complex mechanism. Hence, several experimental studies done on animals never translated into human benefit resulting in gross failure of new drugs including a plethora of neuro protectors, he added.

Many trails dealt with mono therapies instead of adding adjuvant therapies. Animal models did not adequately represent the diversity of patient population. The initial goal of minimizing the brain damage failed purely due to logistic reasons. One thing that came out clear with the clinical research is the principle of ‘Time is Brain’. This means time delay of intervention is related to the loss of brain tissue, he added.

The clinical trials were therefore directed to prevent cell death, to modulate intrinsic pathways to prevent energy failure, to control inflammation through immunomodulation to prevent secondary damage and restore blood brain barrier function as early as possible. However, many therapeutic attempts have failed in proving the benefits due to the challenging mechanisms involved in the stroke as well as lack of an ideal model to perform experiments. Dr Venkataramana told Pharmabiz.

So far the clinical trial models were aimed at to understand the complex biochemical and molecular mechanisms, determine the time of irreversible cell death, electrical failure, inhibition of protein synthesis and energy failure.

There is also a need to develop new therapies to minimize the ischemic injury. Two interventions have revolutionized treatment of acute stroke: thrombolysis dissolving of the clot with a medicine within the period of four and half hours and performing the mechanical endovascular thrombectomy within six hours, particularly useful for large vessel occlusions.

Accordingly, the more and more devices might come in the future. However, due to logistic reasons only less than 10% of acute strokes receive intravenous thrombolysis and only 7-15% are eligible for endovascular intervention, he stated.

The future clinical trials will be aimed to minimize or reverse the area of infarction. Several studies are in progress: The ESCAPE– NAI trial of neuro protective agent is promising but still in infancy. The uric acid protective study called URICO-ICTUS trial to protect the ischemic and reperfusion injury are also in progress. Recent developments in the gene therapy like RNA interference have shown benefit in animal studies for brain ischemia and also hemorrhage.

Stemcell therapies are being tried to improve the outcomes in the acute phase within 72 hours, sub-acute and chronic phase. The initial results seems to be effective for all three phases. The end result of stroke depends upon the number of functioning and effective nerve cells. Here the Defuse and Dawn trials have extended recanulization time up to 24 hours in select groups and initial results seem positive but need validation, he said.

The vagal nerve stimulation (VNS) during the neuro rehabilitation has proven to recover the meaningful movements much faster than otherwise as it regulates the body response to strengthen the motor circuits.

Despite such large understanding, there is a significant road block for the clinical trials in stroke. We need to identify good experimental designs and focus on post stroke complications that affect the quality of life, said Venkataramana.

 

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