The medical company Biogen has announced that the first patient has been enrolled in a Phase 3 clinical trial investigating a drug as a potential treatment for severe cerebral edema associated with large hemispheric infarction. For more detailed information, you can view the source press release here, at Biogen’s website.
About Cerebral Edema in Large Hemispheric Infarction
According to the source article, cerebral edema is a form of brain swelling. It can be associated with a large hemispheric infarction, which is a devastating form of ischemic stroke that, Biogen says, is associated with a mortality rate of 40 to 80% and has no therapy currently available. Ischemic strokes are caused by the blood supply to the brain being cut off by a blockage, such as a blood clot. Ischemic strokes are medical emergencies.
The Investigational Drug
The drug being studied in the Phase 3 CHARM clinical trial is BIIB093 (IV glibenclamide), an investigational drug being developed for the prevention and treatment of severe cerebral edema in large hemispheric infarction. BIIB093 is thought to work by inhibiting SUR1-TRPM4 channels, which are believed to be upregulated after ischemia and trauma.
The Phase 3 CHARM Clinical Trial
The CHARM study is a randomised and double-blind Phase 3 trial that will compare BIIB093 to a placebo. The researchers are hoping to enrol 680 people who have a large hemispheric infarction over around 20 countries. The trial is designed to investigate the efficacy and safety of BIIB093 within ten hours after onset of a stroke.
Preclinical research has supported BIIB093’s role in the inhibition of SUR1-TRPM4 channels, which are involved in brain swelling linked to stroke. Further Phase 2 studies suggested that the drug may be able to reduce brain swelling in people with large hemispheric infarction.
For more information about this topic, you can view the original announcement here. To find out more about the CHARM clinical trial, you can visit www.clinicaltrials.govand use the identifier NCT02864953.