Minocycline for Stroke
Trial Summary
What is the purpose of this trial?
The goal of this study is to determine if oral Minocycline's proposed neuroprotective effects further improve the clinical outcomes, including mortality, of acute stroke patients beyond the current standard stroke care in a large scale randomized prospective open label (outcome assessor blinded) clinical trial. Participants will be randomly assigned (1:1) to take Minocycline 200mg orally every 24 hours for five days, starting within 24 hours from stroke symptoms onset, in addition to standard care or standard care alone. NIHSS (The National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) will be collected at the time of presentation, discharge and again at 30- and 90-days post-discharge. All-cause mortality will also be obtained at 30 days and 90 days.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Minocycline for stroke?
Minocycline has shown promise in animal models and early human trials for its ability to protect the brain by reducing inflammation and cell death after a stroke. It has been found to improve outcomes in animal studies and has a good safety profile in early human trials, suggesting it could be effective in treating stroke.12345
How is the drug minocycline unique for treating stroke?
Minocycline is unique for stroke treatment because it is an antibiotic that also has neuroprotective effects, helping to reduce brain damage by decreasing inflammation and cell death. Unlike standard treatments, it targets multiple pathways to protect brain cells, making it a promising option for improving outcomes in stroke patients.12367
Eligibility Criteria
This trial is for adults over 18 with recent (less than 24 hours) stroke symptoms or imaging showing a stroke, who can take oral medication. It's not for those allergic to Tetracycline drugs, pregnant women, patients with severe illnesses affecting life expectancy within a year, renal failure cases, or existing infections needing antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Minocycline 200 mg orally every 24 hours for five days in addition to standard care or standard care alone
Follow-up
Participants are monitored for safety and effectiveness after treatment, with NIHSS and mRS scores collected at discharge, 30 days, and 90 days post-discharge
Interim Analysis
Interim analyses including safety monitoring conducted at 25%, 50%, and 75% enrollment intervals
Treatment Details
Interventions
- Minocycline
Minocycline is already approved in United States, European Union, Japan, India for the following indications:
- Acne
- Bacterial infections
- Periodontal disease
- Rosacea
- Acne
- Bacterial infections
- Bacterial infections
- Acne
- Rosacea
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maimonides Medical Center
Lead Sponsor