RecruitingPhase 2Phase 3NCT07237048

Minocycline in Stroke Study at Maimonides

Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial


Sponsor

Joyce Chen

Enrollment

1,164 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to determine if Minocycline, when added to standard care, can improve survival and functional outcomes in patients with moderate acute stroke (ischemic or hemorrhagic) aged 18 years and older. The main questions it aims to answer are: 1. Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke? 2. Does Minocycline reduce stroke-related disability, all-cause in hospital mortality (mRS -\*Modified Rankin Scale\* = 6) and at 90 days besides reducing brain bleeding complications compared to standard care? Researchers will compare patients receiving oral Minocycline plus standard care to those receiving standard care only to see if Minocycline leads to better neurological outcomes and lower mortality. Participants will: 1. Be randomly assigned by block to receive either: Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset + Standard Care, or Standard Care only 2. Undergo neurological assessments using NIHSS \*National Institutes of Health Stroke Scale\* and Modified Rankin Scale (mRS) at admission, discharge, 30 days post-stroke, 90 days post-stroke 3. Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses NIHSS: \*National Institutes of Health Stroke Scale\*, which is stroke severity scale, mRS: \*Modified Rankin Scale\*, which is stroke disability scale


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Age \>/=18
  • NIHSS 5-20 \*National Institutes of Health Stroke Scale\*
  • Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO \*(World Health Organization) \* guidelines or acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed
  • The onset of neurological symptoms less than 24 hours

Exclusion Criteria11

  • An individual who meets any of the following criteria is excluded from participation in this study:
  • Clinically stroke is not suspected
  • Allergic to the Tetracycline group of medications or Intolerance to Minocycline
  • Pregnancy or suspected pregnancy or breastfeeding
  • Previous history of intolerance to Minocycline
  • Acute or chronic renal failure (stage III with GFR \*(Glomerular Filtration Rate) \* or Creatinine threshold)
  • Any patients with contraindications to undergo CT (Computed Tomography) / MRI (Magnetic Resonance Imaging)
  • Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission
  • Pre-existing infectious disease requiring antibiotics
  • Inability to tolerate enteral medications/feeds
  • Patient/ family refusal

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Interventions

DRUGMinocycline 200mg

Minocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset.


Locations(1)

Maimonides Medical Center

Brooklyn, New York, United States

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NCT07237048


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