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Anti-inflammatory Antibiotic

Minocycline for Stroke

Phase 2 & 3

Recruiting

Research Sponsored by Maimonides Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO (World Health Organization) guidelines

Acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed

Must not have

Pre-existing infectious disease requiring antibiotics

Patient/ family refusal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on admission, at discharge (within 2 weeks), 30 days and at 90 days after discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate if Minocycline can improve outcomes for stroke patients beyond standard care.

Who is the study for?

This trial is for adults over 18 with recent (less than 24 hours) stroke symptoms or imaging showing a stroke, who can take oral medication. It's not for those allergic to Tetracycline drugs, pregnant women, patients with severe illnesses affecting life expectancy within a year, renal failure cases, or existing infections needing antibiotics.

What is being tested?

The study tests if Minocycline taken orally (200mg daily for five days), starting within the first day of stroke symptoms along with standard care improves outcomes compared to standard care alone. Outcomes are measured using NIHSS and mRS scales at different times post-stroke.

What are the potential side effects?

Minocycline may cause side effects like dizziness, fatigue, gastrointestinal issues such as nausea or diarrhea, skin reactions like rashes or itching and in rare cases may affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I recently had symptoms or imaging results that show a stroke due to lack of blood flow.

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I recently started having trouble with my brain functions due to bleeding inside my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking antibiotics for an infection.

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I or my family have decided not to participate.

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I have kidney failure.

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I cannot tolerate food or medicine by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on admission, at discharge (within 2 weeks), 30 days and at 90 days after discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on admission, at discharge (within 2 weeks), 30 days and at 90 days after discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and on admission, at discharge (within 2 weeks), 30 days and at 90 days after discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

NIHSS (National Institutes of Health Stroke Scale, range 1-42, with higher scores indicating greater severity ) and mRS (Modified Rankin Scale, 0-6, the higher the worse, 6 means dead) Scale)scores) on admission, discharge and on day 90 post-stroke

Secondary study objectives

In-hospital and 30-day mortality

Intracranial hemorrhage in patients treated with intravenous alteplase or catheter-based therapies