Minocycline for moderate acute stroke at Maimonides
Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial
This study will see if adding minocycline to standard care helps adults with moderate acute ischemic or hemorrhagic stroke recover better and survive more often.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT07237048 on ClinicalTrials.gov |
What this trial studies
This randomized, block‑randomized Phase 2/3 trial will enroll 1,164 adults with moderate stroke (NIHSS 5–20) who present within 24 hours of symptom onset at Maimonides Medical Center. Participants are assigned to receive either oral minocycline 200 mg once daily for five days plus standard stroke care, or standard care alone. Outcomes include NIHSS at discharge and 90 days, modified Rankin Scale (mRS) at discharge, 30 and 90 days, in-hospital and 90-day mortality, and monitoring for intracranial bleeding complications. The trial builds on prior single-center clinical experience and observational data suggesting possible neuroprotective and anti-inflammatory effects of minocycline.
Who should consider this trial
Good fit: Adults aged 18 or older with acute ischemic or intracerebral hemorrhagic stroke, NIHSS 5–20, and symptom onset less than 24 hours who are not pregnant and have no contraindication to tetracyclines are the intended candidates.
Not a fit: People with very mild or extremely severe strokes outside the NIHSS 5–20 range, symptoms more than 24 hours old, known allergy or intolerance to tetracyclines, significant renal failure, or who are pregnant/breastfeeding are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, adding an inexpensive, widely available drug could reduce disability and deaths after moderate acute stroke.
How similar studies have performed: Smaller observational studies and single-center experience have reported improved outcomes with minocycline, but no large randomized trial has yet confirmed those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
\* Inclusion criteria In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age \>/=18 2. NIHSS 5-20 \*National Institutes of Health Stroke Scale\* 3. 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 4. The onset of neurological symptoms less than 24 hours * Exclusion criteria An individual who meets any of the following criteria is excluded from participation in this study: 1. Clinically stroke is not suspected 2. Allergic to the Tetracycline group of medications or Intolerance to Minocycline 3. Pregnancy or suspected pregnancy or breastfeeding 4. Previous history of intolerance to Minocycline 5. Acute or chronic renal failure (stage III with GFR \*(Glomerular Filtration Rate) \* or Creatinine threshold) 6. Any patients with contraindications to undergo CT (Computed Tomography) / MRI (Magnetic Resonance Imaging) 7. Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission 8. Pre-existing infectious disease requiring antibiotics 9. Inability to tolerate enteral medications/feeds 10. Patient/ family refusal
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Principal investigator: Qingliang T. Wang, MD, PhD — Maimonides Medical Center
- Study coordinator: Qingliang T. Wang, MD, PhD
- Email: qwang@maimo.org
- Phone: 718.283.7670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.