Maimonides Minocycline in Stroke Study

NCT06107725 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2023-05-16-MMC
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine if oral Minocycline's proposed neuroprotective effects further improve the clinical outcomes, including mortality, of acute stroke patients beyond the current standard stroke care in a large scale randomized prospective open label (outcome assessor blinded) clinical trial. Participants will be randomly assigned (1:1) to take Minocycline 200mg orally every 24 hours for five days, starting within 24 hours from stroke symptoms onset, in addition to standard care or standard care alone. NIHSS (The National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) will be collected at the time of presentation, discharge and again at 30- and 90-days post-discharge. All-cause mortality will also be obtained at 30 days and 90 days.

Conditions

Stroke, Acute; Ischemic Stroke; Hemorrhagic Stroke; Mortality; Morbidity

Keywords

Minocycline; Acute Stroke; Neuroprotection; Mortality; Morbidity; Ischemic stroke; Hemorrhagic Stroke; mRs (Modified Rankin Scale); Clinical outcome

Outcome Measures

Primary Outcomes (1)

• In-hospital and 30-day Mortality

  Mortality rates during hospitalization and at 30 days

  30 days

Study Arms (2)

Standard Stroke Care without Minocycline

NO INTERVENTION

560 Patients will receive standard stroke care.

Standard Stroke Care with Minocycline

EXPERIMENTAL

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

Drug: Minocycline

Interventions

Minocycline DRUG

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

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:

• Age \>/=18
• 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
• The onset of symptoms less than 24 hours
• Measurable neurological deficit using NIHSS (National Institutes of Health Stroke Scale )

You may not qualify if:

• Clinically not suspect stroke.
• Allergic to the Tetracycline group of medications or Intolerance to Minocycline
• Pregnancy or suspected pregnancy
• Previous history of intolerance to minocycline
• Acute or chronic renal failure
• Any patients with contraindications to undergo CT/ MRI
• 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

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. QingL Tony Wang
• Organization: Maimonides Medical Center

qwang@maimo.org

718.283.7670

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will contact and obtain primary outcome measures of mRS without the knowledge of participants group assignment/treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Vice Chair of Neurology; Director of Jaffe Comprehensive Stroke Center

Model Details: Randomized, open label study

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)