StrokePhase 2/3NCT07237048
Minocycline in Stroke Study at Maimonides
A Phase 2/3 study testing Minocycline 200mg in people with Stroke and Ischemia Stroke, run by Joyce Chen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemia Stroke, Hemorrhagic Strokes
- What is being tested?
- Minocycline 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,164 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ilya Levin, DO contact
United States1 site, 1 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Qing Tony Wang, MD, 718-283-7670, qwang@maimo.org
About this study
Official title: 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:
Read more
- Does Minocycline improve *National Institutes of Health Stroke Scale* (NIHSS) scores at hospital discharge and 90 days post-stroke?
- 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:
- 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
- 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
- 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
Read the 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*
- Conditions
- Stroke, Ischemia Stroke, Hemorrhagic Strokes, Mortality, Morbidity, Cerebrovascular Accident (Stroke)
- Being tested
- Minocycline 200mg
- 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
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebral Hemorrhage, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline 200mgDrug
Also called Minocin, Minocycline hydrochloride
Minocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Minocycline 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 90 days (+/- 7 days) after stroke onset
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 90 days (±7 days) after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start2 Feb 2026
- Primary completion1 Dec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label, prospective
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joyce Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joyce Chen, Maimonides Medical Center
- Investigators
- Qingliang T. Wang, MD, PhD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237048
- Sponsor's protocol ID
- 2024-05-01-MMC
- Other IDs
- Internal Stroke Research Funds
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial
- ClinicalTrials.gov ID
- NCT07237048
- Acronym / sponsor ID
- 2024-05-01-MMC
- Conditions
- Stroke, Ischemia Stroke, Hemorrhagic Strokes, Mortality, Morbidity, Cerebrovascular Accident (Stroke)
- Keywords
- Minocycline, Acute Stroke, Neuroprotection, Ischemic Stroke, Hemorrhagic Stroke, NIH Stroke Scale, Modified Rankin Scale (mRS), Stroke Recovery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,164 participants (estimated)
- Lead sponsor
- Joyce ChenUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Minocycline improve *National Institutes of Health Stroke Scale* (NIHSS) scores at hospital discharge and 90 days post-stroke?
- 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:
- 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
- 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
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, open label, prospective
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Minocycline 200mg582 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline 200mgAlso: Minocin, Minocycline hydrochlorideMinocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset. | Drug | Standard Stroke Care with Minocycline |
Primary outcome
Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke
Time frame: At day 7 after stroke onset
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.
Change in National Institutes of Health Stroke Scale (NIHSS) Score at 90 days (+/- 7 days) post-stroke
Time frame: At 90 days (+/- 7 days) after stroke onset
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.
3 secondary outcomes
NIHSS Score at 30 Days Post-Stroke
Time frame: up to 30 days after stroke onset
Rate of Hemorrhagic Transformation of Ischemic Strokes
Time frame: 22-36 hours post treatment
All-Cause Mortality (mRS = 6)
Time frame: Up to 90 days (±7 days) after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilya Levin, DO contact
Qingliang T. Wang, MD, PhD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Minocycline 200mg in people with Stroke and Ischemia Stroke, run by Joyce Chen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingliang T. Wang, MD, PhD (718.283.7670, qwang@maimo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.