A Phase 2/3 interventional study of Minocycline 200mg in Stroke, Ischemia Stroke and Hemorrhagic Strokes, sponsored by Joyce Chen. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Joyce Chen · Phase 2/3, Interventional, and Treatment
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:
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
NIHSS: *National Institutes of Health Stroke Scale*, which is stroke severity scale,
mRS: *Modified Rankin Scale*, which is stroke disability scale
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*
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's planned enrollment of 1,164 is above the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →This is the only study on the registry with Joyce Chen as lead sponsor.
Compared within Hemorrhagic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
* Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
The onset of neurological symptoms less than 24 hours
An individual who meets any of the following criteria is excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
582 Patients in this arm will receive standard stroke care, No Minocycline will be given
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.
Also known as: Minocin, Minocycline hydrochloride
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.
Time frame: 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.
Time frame: At 90 days (+/- 7 days) after stroke onset
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 days (±7 days) after stroke onset
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Minocycline