Deans' stroke musings: FDA places hold on phase 2/3 clinical trial of stroke therapy

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, August 6, 2022

FDA places hold on phase 2/3 clinical trial of stroke therapy

What is your doctor's competence level on knowing about this research? NONE?

FDA places hold on phase 2/3 clinical trial of stroke therapy

Biopharmaceutical company DiaMedica Therapeutics Inc. announced that the FDA placed a clinical hold on its phase 2/3 ReMEDy2 trial of a synthetic protein therapy for treatment of acute ischemic stroke.

According to a press release, the hold was initiated following DiaMedica’s pausing of patient enrollment and submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension that occurred shortly after initiation of an IV dose of the therapeutic DM199. Blood pressure levels of the three patients recovered back to their baseline blood pressure within minutes after IV infusion was stopped, per the release.

FDAsign_323811316 — Source: Adobe Stock.

“Patient safety is very important as we plan and conduct our clinical studies,” Kirsten Gruis, MD, chief medical officer of DiaMedica, stated in the release. “Patient blood pressure is easily and routinely monitored in stroke patients, which is why our study sites were able to quickly identify the issue and immediately stop the dosing of DM199, after which the patients then recovered within minutes and suffered no injuries.”

DiaMedica stated it believes the adverse events resulted from switching to an IV bag formulated from different materials in the ReMEDy2 trial compared with the IV bag used in the prior phase 2 ReMEDy1 trial.

As a result of the hold, DiaMedica may not enroll any additional patients in the ReMEDy2 trial until it provides the FDA with analysis of the events leading to or causing the hypotension, provides suggested protocol modifications to address the mitigation of these events, supplies a rationale and supporting data for the protocol modifications, and the FDA notifies DiaMedica that it may resume enrollment.

“While having to pause enrollment in the ReMEDy2 trial was not desirable, we remain confident about the future potential of DM199 and are committed to refining the dosing procedures and methods that will further enhance patient safety,” DiaMedica President and CEO Rick Pauls said in the release.