Minocycline for Stroke

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Disqualifiers: Allergy to tetracycline, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests minocycline, a drug that may help prevent complications after a brain aneurysm bursts. Researchers aim to determine if minocycline can reduce the risk of vasospasm, a condition where blood vessels narrow and cause strokes. They are also examining whether certain body markers can predict who might experience these complications. People with a recent ruptured brain aneurysm, who do not have allergies to tetracycline antibiotics and do not have liver or kidney failure, may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that minocycline is likely to be safe for humans?

Research has shown that minocycline is safe and generally well-tolerated. Studies have found that doses up to 10 mg/kg can be safely administered intravenously, meaning directly into the vein. It has been tested both alone and with other treatments like tPA, a medication used for stroke treatment. Participants in these studies did not experience serious side effects, indicating that minocycline is usually safe. Therefore, for those considering joining a trial with minocycline, past research suggests it should be well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Minocycline is unique because it offers a novel approach to treating strokes by potentially reducing inflammation and protecting brain cells. Unlike current treatments that mainly focus on dissolving blood clots, like tissue plasminogen activator (tPA), minocycline works as an anti-inflammatory and neuroprotective agent. Researchers are excited about this treatment because it might be used alongside existing therapies to improve outcomes and can be administered even hours after a stroke, offering more flexibility in treatment timing.

What evidence suggests that minocycline might be an effective treatment for cerebral vasospasm?

Research has shown that minocycline may aid in stroke recovery. In earlier studies, patients who took minocycline after a stroke experienced significantly better recovery outcomes. Minocycline blocks a protein called MMP9, which is associated with the breakdown of the brain's protective barrier and swelling. This action helps protect the brain and reduce damage during a stroke. While it remains uncertain if minocycline will assist with cerebral vasospasm (the narrowing of blood vessels in the brain) after a burst aneurysm, its positive effects on stroke recovery are promising. Researchers continue to explore the drug's potential to prevent these issues, and early results are hopeful. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high dose intravenous Minocycline treatment to assess its effect on BBB permeability and serum MMP9 levels

2 weeks

Daily monitoring in the intensive care unit

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on clinical vasospasm and safety profile

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minocycline

Trial Overview The 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 for the following indications:

Approved in United States as Minocin for:

• Acne
• Bacterial infections
• Periodontal disease
• Rosacea

Approved in European Union as Minostad for:

• Acne

Approved in Japan as Minopen for:

• Bacterial infections

Approved in India as Minoz for:

• Bacterial infections

Approved in United States as Amzeeq for:

• Acne

Approved in United States as Zilxi for:

• Rosacea

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

In a study of 50 acute ischemic stroke patients, those treated with oral minocycline showed significant improvements in clinical outcomes, including NIHSS, mRS, and Barthel Index scores at 30 and 90 days compared to the control group receiving vitamin B.

No serious adverse effects, such as mortality or recurrent strokes, were reported in either group, indicating that minocycline is a safe option for improving recovery after an acute ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of minocycline in acute ischemic stroke: a single-blinded, placebo-controlled trial. Padma Srivastava, MV., Bhasin, A., Bhatia, R., et al.[2019]

Minocycline, a tetracycline antibiotic, shows potential as a neuroprotective agent in acute ischemic stroke, demonstrating effects on reducing cell death, inflammation, and injury in both animal models and early human trials.

Current systemic thrombolytic therapies for stroke are limited by strict eligibility criteria and risks of bleeding, highlighting the need for alternative treatments like minocycline that may improve long-term outcomes without these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline repurposing in critical illness: focus on stroke. Liao, TV., Forehand, CC., Hess, DC., et al.[2021]

In a study involving 16 patients with intracerebral hemorrhage, intravenous minocycline was found to be safe and maintained neuroprotective serum concentrations, indicating its potential as a treatment option.

However, the oral form of minocycline showed delayed absorption, taking at least 6 hours to reach peak concentration, which may limit its effectiveness in acute situations where rapid action is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Fouda, AY., Newsome, AS., Spellicy, S., et al.[2019]

Minocycline, an antibiotic with neuroprotective properties, has shown promise in reducing brain damage and improving recovery in animal models of stroke, making it a strong candidate for treating acute ischemic stroke due to its ability to cross the blood-brain barrier and its good safety profile.

Early phase clinical trials indicate that minocycline is safe and may be effective in treating acute ischemic stroke, either alone or with other treatments, but further large-scale studies are necessary to confirm its efficacy and determine its role in stroke therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline development for acute ischemic stroke. Fagan, SC., Cronic, LE., Hess, DC.[2021]

Minocycline, administered intravenously within 6 hours of stroke onset, was found to be safe and well tolerated at doses up to 10 mg/kg, with only one instance of dose-limiting toxicity reported.

The drug has a half-life of approximately 24 hours, suggesting it can be effectively dosed every 24 hours, making it a potentially ideal treatment option to use alongside tissue plasminogen activator in acute ischemic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline to improve neurologic outcome in stroke (MINOS): a dose-finding study. Fagan, SC., Waller, JL., Nichols, FT., et al.[2023]

Minocycline, traditionally an antibiotic, shows potential as a cardiovascular therapeutic due to its anti-inflammatory, antioxidant, and antiapoptotic properties, as supported by preclinical and clinical studies.

The review highlights ongoing clinical trials investigating minocycline's cardioprotective effects, emphasizing its promising role beyond its original use as an antibiotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline: a bacteriostatic antibiotic with pleiotropic cardioprotective effects. Brenes-Salazar, JA.[2015]

Minocycline, a commonly used antibiotic, has shown potential beyond its traditional use, demonstrating cytoprotective and neuroprotective effects that may benefit patients with cerebrovascular and neurodegenerative diseases.

Current literature suggests that minocycline's multi-faceted effects on cell functions make it a promising candidate for clinical trials targeting various conditions, including bacterial infections, cancer, and autoimmune disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minocycline mediated mitochondrial cytoprotection: premises for therapy of cerebrovascular and neurodegenerative diseases. Karachitos, A., García Del Pozo, JS., de Groot, PW., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3916214/

Minocycline to Improve Neurologic Outcome in Stroke (MINOS) Even when the drug was administered orally for 5 days after acute ischemic stroke, significantly better stroke outcome was reported.An oral dose would achieve ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05367362?intr=DYNACIN&aggFilters=studyType:int&viewType=Table&rank=1

Study Details | Minocycline Efficacy in Improving Neurological ... Minocycline Efficacy in Improving Neurological Outcome of Patients Who Undergo Endovascular Revascularization for Acute Ischemic Stroke. ClinicalTrials.gov ...

3. svn.bmj.com svn.bmj.com/content/early/2025/03/26/svn-2024-003577

Rationale and Study Design to Assess the Efficacy ... Attenuation of acute stroke injury in rat brain by minocycline promotes blood–brain barrier remodeling and alternative microglia/macrophage ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006899325005037

Optimized dose of hydrogen-enriched water with ... Hydrogen (H2) treatment had a dose dependent effect on stroke outcomes. •. The optimal H2 dose reduced infarct volume and improved functional ...

5. scholars.uky.edu scholars.uky.edu/en/projects/minocycline-to-improve-neurologic-outcomes-3/

Minocycline to Improve Neurologic Outcomes - Scholars@UK This is a research study about minocycline, a widely used antibiotic that may improve recover after a stroke. Participants will have had a stroke caused by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3169090/

Minocycline Development for Acute Ischemic Stroke - PMC In 2010, the MINOS trial found minocycline to be safe and well tolerated in intravenous doses up to 10 mg/kg alone and when administered with tPA. The patients ...

7. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.110.582601

Minocycline to Improve Neurologic Outcome in Stroke ... Conclusions—Minocycline is safe and well tolerated up to doses of 10 mg/kg intravenously alone and in combination with tissue plasminogen ...