Last updated: December 15, 2023
Sponsor: Stony Brook University
Overall Status: Completed
Phase
2/3
Condition
Cardiac Ischemia
Thrombosis
Stroke
Treatment
Hydrogen
Minocycline
Placebo Minocycline
Clinical Study ID
NCT03320018
932805
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pre-existing neurological disability (historical NIHSS > 3); unable to liveindependently 3. Severe stroke or comorbidities likely to result in patient dying within 3months 4. Acute or chronic renal failure with calculated creatinine clearance < 30 5. Liverdisease leading to > 3x elevation in liver transaminases or significant loss of syntheticcapacity* 6. Thrombocytopenia (<100x10^9platelets / L blood) 7. Pre-existing infectiousdisease requiring antibiotic therapy that have a negative interaction with minocycline. (Penicillin, amoxicillin, ampicillin, bacampicillin, carbenicillin, cloxacillin,dicloxacillin, methicillin, mezlocillin, nafcillin, oxacillin, piperacillin, ticarcillin)
- Pregnancy or nursing. Females of reproductive age will be required to use barriercontraception or abstain from sexual intercourse while on study medications, as minocyclinemay render oral contraceptives less effective.
- Known allergy to tetracycline group of drugs 10. Concurrent treatment with retinoids orergot alkaloids 11. Inability to safely tolerate the fluid load (iv normal saline or powater) associated with study medication* 12. Treatment with another investigational drugwithin the last 30 days that may interfere with this study's medications* 13. Inability totolerate or comply with study procedures*
Study Design
Total Participants: 15
Treatment Group(s): 4
Primary Treatment: Hydrogen
Phase: 2/3
Study Start date:
August 02, 2017
Estimated Completion Date:
August 13, 2019
Study Description
Connect with a study center
Stony Brook University Hospital
Stony Brook, New York 11794-8121
United StatesSite Not Available

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