Status:
COMPLETED
Neuroprotection in Acute Ischemic Stroke
Lead Sponsor:
Stony Brook University
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a pilot randomized control trial (RCT) to explore the possible beneficial effect of a novel combination therapy consisting of molecular hydrogen H2 plus minocycline ("H2M"), on neurological re...
Detailed Description
This will be a pilot trial exploring the ability of a novel combination ("H2M") of molecular hydrogen (an antioxidant) and minocycline (a widely used antibiotic known to inhibit the activation of matr...
Eligibility Criteria
Inclusion
- Aged 18 years old or over
- Presenting to/at Stony Brook University Hospital with acute ischemic stroke
- Baseline (at admission to study) National Institute of Health Stroke Scale (NIHSS) of ≥ 5
- Administration of study medication possible within 24 hours of last known well
Exclusion
- 1\. Pre-existing neurological disability (historical NIHSS \> 3); unable to live independently 3. Severe stroke or comorbidities likely to result in patient dying within 3 months 4. Acute or chronic renal failure with calculated creatinine clearance \< 30 5. Liver disease leading to \> 3x elevation in liver transaminases or significant loss of synthetic capacity\* 6. Thrombocytopenia (\<100x10\^9platelets / L blood) 7. Pre-existing infectious disease requiring antibiotic therapy that have a negative interaction with minocycline. (Penicillin, amoxicillin, ampicillin, bacampicillin, carbenicillin, cloxacillin, dicloxacillin, methicillin, mezlocillin, nafcillin, oxacillin, piperacillin, ticarcillin) 8. Pregnancy or nursing. Females of reproductive age will be required to use barrier contraception or abstain from sexual intercourse while on study medications, as minocycline may render oral contraceptives less effective.
- 9\. Known allergy to tetracycline group of drugs 10. Concurrent treatment with retinoids or ergot alkaloids 11. Inability to safely tolerate the fluid load (iv normal saline or po water) associated with study medication\* 12. Treatment with another investigational drug within the last 30 days that may interfere with this study's medications\* 13. Inability to tolerate or comply with study procedures\*
Key Trial Info
Start Date :
August 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03320018
Start Date
August 2 2017
End Date
August 13 2019
Last Update
December 19 2023
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8121