FDA Places Clinical Hold on DiaMedica’s Acute Ischemic Stroke Clinical Trial

The FDA placed a clinical hold on DiaMedica Therapeutics’ phase 2/3 clinical trial, which was examining its investigational drug, DM199, in acute ischemic stroke patients.

The agency called for the hold because of three serious adverse events involving study participants experiencing clinically significant, transient hypotension, also known as low blood pressure, shortly after beginning an intravenous treatment.

Because the three patients recovered shortly after the IV infusion was stopped, the company is investigating the IV bags as a possible cause, but is also considering reduced doses and IV infusion times to resolve the issue.

The FDA expects the company to provide an analysis of the events leading to or causing the hypotension, as well as suggested protocol changes and supporting data. In the meantime, no additional patients can be enrolled in the clinical trial.