Actively Recruiting
Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial
Led by Joyce Chen · Updated on 2026-03-19
1164
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding Minocycline, a low-cost antibiotic with potential brain-protective effects, to standard care can improve survival and functional outcomes for adults aged 18 and older who have experienced a moderate acute stroke, either ischemic or hemorrhagic. The study focuses on whether Minocycline improves neurological status and reduces disability, death rates, and brain bleeding complications compared to standard stroke care alone. Participants will be randomly assigned to one of two groups: one will receive 200 mg of oral Minocycline once daily for five days starting within 24 hours of stroke symptoms plus standard care, while the other group will receive only standard stroke care without Minocycline. The trial is open-label and prospective, aiming to enroll 1,164 adults with moderate stroke severity. Assessments will be conducted at hospital admission, discharge, and up to 90 days after stroke onset. During the study, participants will undergo neurological evaluations using the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) at specified time points to measure stroke severity and disability. Researchers will monitor for hemorrhagic transformation, adverse events, mortality, and safety signals through interim analyses. The primary outcome includes changes in NIHSS scores at day 7 and at 90 days post-stroke, with additional monitoring for complications and survival up to 90 days. Participation may last up to three months from stroke onset.
CONDITIONS
Brief Title
Minocycline in Stroke Study at Maimonides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- NIHSS score between 5 and 20 indicating moderate stroke severity
- Acute neurological deficit consistent with ischemic stroke or intracerebral hemorrhage confirmed by imaging
- Onset of neurological symptoms less than 24 hours before enrollment
You will not qualify if you...
- Stroke is not clinically suspected
- Allergy or intolerance to Minocycline or tetracycline antibiotics
- Pregnancy, suspected pregnancy, or breastfeeding
- Acute or chronic renal failure (stage III with specific kidney function thresholds)
- Contraindications to CT or MRI imaging
- Life expectancy less than one year or severe co-morbid conditions
- Pre-existing infections requiring antibiotics
- Inability to tolerate oral medications or feeds
- Patient or family refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive either Minocycline 200 mg orally once daily for five days along with standard stroke care, or standard stroke care alone.
Daily visits or assessments during treatment
Duration - Up to 90 days after stroke onset
Participants are monitored for stroke severity, disability, and safety outcomes after treatment ends.
Visits at hospital discharge, 30 days, and 90 days post-stroke
Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
Research Team
Q
Qingliang T. Wang, MD, PhD
I
Ilya Levin, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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