Minocycline for Stroke

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Prior Safety Data

Approved in 7 Jurisdictions

Trial Summary

What is the purpose of this trial?

Previous work has demonstrated patients presenting with ruptured aneurysms that develop radiographic and clinical vasospasm have a higher permeability of the blood brain membrane. Matrix metalloproteinase 9 (MMP9) has been studied and recently implicated in both the pathogenesis of the blood brain barrier breakdown and vasogenic edema of ischemia strokes, and is suggested to be an accurate biomarker to predict the onset of cerebral vasospasm after subarachnoid hemorrhage. The therapeutic benefit of minocycline, an MMP9 inhibitor, has been investigated in ischemic stroke population, however its role in the treatment of cerebral vasospasm from ruptured aneurysms remains unknown. Our project has two main goals: to further confirm MMP9 has a reliable biomarker for the onset of cerebral vasospasm, and secondarily to investigate any possible therapeutic benefit that minocycline has in the vasospasm population. Vasospasm continues to be one of the major contributors of morbidity and mortality in the ruptured aneurysm population, and close monitoring of the neurologic exam during the 'vasospasm window' usually requires two weeks in the intensive care unit in most academic settings. As such, if we are better able to predict which patients are at risk of developing vasospasm based on MMP9 levels, we will be better able to anticipate the need for intervention and therefore mitigate the risk of vasospasm induced ischemic strokes, ultimately resulting in better outcomes in the ruptured aneurysm population. Further, if we are able to identify minocycline as a therapeutic agent to deter, or lessen the severity of vasospasm, we can possibly improve neurologic outcomes, decrease hospital stays, ultimately providing an improved and more cost-effective treatment strategy to our patients.

Eligibility Criteria

This trial is for adults aged 18 to 85 who have had a ruptured cerebral aneurysm and can start the trial within 24 hours of the rupture. It's not suitable for those allergic to tetracycline, pregnant individuals, or people with liver or kidney failure.

Inclusion Criteria

I am between 18 and 85 years old.

I have had a ruptured brain aneurysm.

I was enrolled in the study within a day of my rupture.

Exclusion Criteria

I have kidney failure.

My liver is not working properly.

You are allergic to tetracycline.

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Treatment Details

Interventions

Minocycline (Antibiotic)

Trial OverviewThe MASH trial is testing whether minocycline, which inhibits MMP9 (a molecule involved in brain damage after bleeding), can predict and reduce complications from blood vessel spasms after a brain hemorrhage due to aneurysm rupture.

Minocycline is already approved in United States, European Union, Japan, India, United States, United States for the following indications:

🇺🇸 Approved in United States as Minocin for: