Minocycline in Stroke Study at Maimonides

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Mortality; Cerebrovascular Accident (Stroke); Morbidity; Intracerebral Haemorrhage (ICH); Hemorrhagic Strokes; Ischemia Stroke
• Intervention / Treatment: Drug: Minocycline 200mg

Detailed Description

Stroke is a major cause of death and disability in the United States. While treatments such as clot-busting drugs (tPA or TNK) and thrombectomy can help some patients with ischemic strokes, there are limited options for protecting the brain after a stroke. Minocycline is a low-cost antibiotic that may have protective effects on the brain due to its anti-inflammatory and neuroprotective properties.

At Maimonides Medical Center, we have used Minocycline for all eligible patients with acute strokes in clinical practice until March 2019, Studies found that Minocycline was associated with better stroke outcomes and lower death rates, especially in patients with moderate stroke severity. However, no large, randomized trial has yet confirmed its benefits.

This study will prospectively enroll 1,164 adults with moderate stroke (National Institutes of Health Stroke Scale 5-20) within 24 hours of symptom onset. Participants will be assigned by block randomization to receive either:

Minocycline 200 mg orally once daily for 5 days + standard stroke care, or Standard stroke care alone.

The study will measure stroke severity (using the *NIHSS*- National Institutes of Health Stroke Scale) and disability (using the mRS - *modified Rankin Scale*) at hospital discharge, 30 days, and 90 days. It will also monitor for death and any bleeding complications in the brain.

The goal is to see whether Minocycline, in addition to usual care, can safely improve recovery and survival in people with acute stroke. The results could help guide future stroke treatment nationwide.

NIHSS: *National Institutes of Health Stroke Scale*, is stroke severity scale, mRS: *Modified Rankin Scale*, is stroke disability scale, WHO: *World Health Organization*

• Study Type: Interventional
• Enrollment (Estimated): 1164
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Qingliang T. Wang, MD, PhD; Phone Number: 718.283.7670; Email: qwang@maimo.org
• Study Contact Backup: Name: Ilya Levin, DO; Phone Number: 718.283.8681

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Recruiting
      • Maimonides Medical Center
      • Contact: Qing Tony Wang, MD; Phone Number: 718-283-7670; Email: qwang@maimo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

* Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age >/=18
2. NIHSS 5-20 *National Institutes of Health Stroke Scale*
3. 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

4. The onset of neurological symptoms less than 24 hours

   • Exclusion criteria

An individual who meets any of the following criteria is excluded from participation in this study:

1. Clinically stroke is not suspected
2. Allergic to the Tetracycline group of medications or Intolerance to Minocycline
3. Pregnancy or suspected pregnancy or breastfeeding
4. Previous history of intolerance to Minocycline
5. Acute or chronic renal failure (stage III with GFR *(Glomerular Filtration Rate) * or Creatinine threshold)
6. Any patients with contraindications to undergo CT (Computed Tomography) / MRI (Magnetic Resonance Imaging)
7. Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission
8. Pre-existing infectious disease requiring antibiotics
9. Inability to tolerate enteral medications/feeds
10. Patient/ family refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Minocycline 200mg; Minocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset.; Other Names: Minocin; Minocycline hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke	The NIHSS score will be assessed at Day 7 post-stroke to measure neurological impairment and recovery. The primary outcome is the difference in NIHSS scores between the Minocycline plus standard care group and the standard care alone group.	At day 7 after stroke onset
Change in National Institutes of Health Stroke Scale (NIHSS) Score at 90 days (+/- 7 days) post-stroke	The NIHSS score will be assessed 90 days (+/- 7 days) post-stroke to measure neurological impairment and recovery. The primary outcome is the difference in NIHSS scores between the Minocycline plus standard care group and the standard care alone group.	At 90 days (+/- 7 days) after stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS Score at 30 Days Post-Stroke	NIHSS scores will be assessed at 30 days (+/- 7 days) post-stroke to evaluate intermediate neurological recovery in both treatment arms.	up to 30 days after stroke onset
Rate of Hemorrhagic Transformation of Ischemic Strokes	The incidence of hemorrhagic transformation in ischemic stroke patients treated with IV thrombolytics and/or thrombectomy will be assessed during hospitalization using ECASS ( European Cooperative Acute Stroke Study) II/III criteria via follow-up CT or MRI imaging.	22-36 hours post treatment
All-Cause Mortality (mRS = 6)	Mortality rates will be measured at Day 7, 30 days (+/- 7 days), and 90 days (+/- 7 days) post-stroke in both treatment groups.	Up to 90 days (±7 days) after stroke onset

Collaborators and Investigators

• Sponsor: Joyce Chen
• Investigators: Principal Investigator: Qingliang T. Wang, MD, PhD, Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Morbidity; Mortality; Ischemic Stroke; NIH Stroke Scale; Neuroprotection; Acute Stroke; Minocycline; Mechanical Thrombectomy; Hemorrhagic Stroke; Intravenous Thrombolysis; Stroke Recovery; Modified Rankin Scale (mRS); Stroke Treatment; Stroke Outcomes; Hemorrhagic Transformation; Oral antibiotic
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Hemorrhagic Stroke; Stroke; Cerebral Hemorrhage; cyclopia sequence; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Minocycline
• Other Study ID Numbers: 2024-05-01-MMC; Internal Stroke Research Funds (Other Grant/Funding Number: Internal Stroke Research Funds)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No