Minocycline in Stroke Study at Maimonides

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Joyce Chen
Study ID
NCT07237048
Phase
PHASE2/PHASE3
Status
Recruiting

Conditions

  • Cerebrovascular Accident (Stroke)
  • Hemorrhagic Strokes
  • Intracerebral Haemorrhage (ICH)
  • Ischemia Stroke
  • Morbidity
  • Mortality
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Dec 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard Stroke Care without Minocycline
    582 Patients in this arm will receive standard stroke care, No Minocycline will be given
  • Experimental: Standard Stroke Care with Minocycline
    582 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care

Primary Outcome Measure

Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke [ Time Frame: At day 7 after stroke onset ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219
Qing Tony Wang, MD
718-283-7670

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