Using Minocycline to improve outcomes in stroke patients
Effect of Oral Minocycline on Acute Stroke Outcome: A Randomized Open Label Prospective Study
This study is testing if adding the antibiotic Minocycline to regular stroke treatment can help patients recover better after a stroke.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06107725 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of oral Minocycline in enhancing clinical outcomes for patients experiencing acute strokes. Participants will be randomly assigned to receive either Minocycline in addition to standard stroke care or standard care alone. The study will assess outcomes such as mortality and functional recovery using established scales at various time points. The trial will enroll 1120 patients over a two-year period, starting within 24 hours of stroke symptom onset.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present with acute ischemic stroke or intracerebral hemorrhage within 24 hours of symptom onset.
Not a fit: Patients who are not experiencing a stroke or have contraindications to Minocycline will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and functional recovery for acute stroke patients.
How similar studies have performed: Previous studies have indicated potential neuroprotective effects of Minocycline, suggesting this approach may be promising but it remains to be fully validated in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>/=18 2. Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO (World Health Organization) guidelines 3. Acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed 4. The onset of symptoms less than 24 hours 5. Measurable neurological deficit using NIHSS (National Institutes of Health Stroke Scale ) Exclusion Criteria: 1. Clinically not suspect stroke. 2. Allergic to the Tetracycline group of medications or Intolerance to Minocycline 3. Pregnancy or suspected pregnancy 4. Previous history of intolerance to minocycline 5. Acute or chronic renal failure 6. Any patients with contraindications to undergo CT/ MRI 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
- Study coordinator: Qingliang T Wang, MD., PhD
- Email: QWang@maimonidesmed.org
- Phone: 7182837670
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.