Minocycline in Stroke Study at Maimonides

NCT07237048 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-05-01-MMCInternal Stroke Research Funds
• Study Type: interventional
• Target: 1,164
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke?
2. 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?
3. 3.Be randomly assigned by block to receive either:
4. 4.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
5. 5.Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses

Conditions

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

Keywords

Minocycline; Acute Stroke; Neuroprotection; Ischemic Stroke; Hemorrhagic Stroke; NIH Stroke Scale; Modified Rankin Scale (mRS); Stroke Recovery; Stroke Treatment; Stroke Outcomes; Morbidity; Mortality; Intravenous Thrombolysis; Mechanical Thrombectomy; Hemorrhagic Transformation; Oral antibiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• NIHSS Score at 30 Days Post-Stroke

  up to 30 days after stroke onset

• Rate of Hemorrhagic Transformation of Ischemic Strokes

  22-36 hours post treatment

• All-Cause Mortality (mRS = 6)

  Up to 90 days (±7 days) after stroke onset

Study Arms (2)

Standard Stroke Care without Minocycline

NO INTERVENTION

582 Patients in this arm will receive standard stroke care, No Minocycline will be given

Standard Stroke Care with Minocycline

EXPERIMENTAL

582 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care

Drug: Minocycline 200mg

Interventions

Minocycline 200mg DRUG

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

Also known as: Minocin, Minocycline hydrochloride

Standard Stroke Care with Minocycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joyce Chen: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Cerebral Hemorrhage; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Qingliang T. Wang, MD, PhD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingliang T. Wang, MD, PhD

CONTACT

718.283.7670; qwang@maimo.org

Ilya Levin, DO

CONTACT

718.283.8681

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an outcome assessor-blinded study. Independent outcome assessor will contact participants and obtain primary outcome measures of mRS \*(Modified Rankin Scale) \* and NIHSS \*(National Institute of Stroke Scale) \* without the knowledge of participants group assignment/treatment received to reduce the bias and improve validity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Data Analyst

Model Details: Randomized, open label, prospective

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: November 19, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)