Neuroprotection in Acute Ischemic Stroke

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

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 recovery after acute ischemic stroke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 years old or over
  2. Presenting to/at Stony Brook University Hospital with acute ischemic stroke
  3. Baseline (at admission to study) National Institute of Health Stroke Scale (NIHSS) of ≥ 5
  4. Administration of study medication possible within 24 hours of last known well

Exclusion

Exclusion Criteria:

  1. 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)
  2. 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.
  3. 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

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 matrix metallo-proteinase-9 and poly(ADP-ribose) polymerase), to protect brain tissue from ischemia/reperfusion injury that occurs during and after an ischemic stroke. Both hydrogen and minocycline have excellent safety profiles, have been previously demonstrated individually to reduce infarction in animal models of stroke, and have potentially synergistic mechanisms of action against ischemic brain damage. The mechanisms of action of both agents would be specifically relevant to patients receiving tissue plasminogen activator (tPA) or thrombectomy, and achieving some degree of therapeutic reperfusion.

This will be a double blinded, placebo-controlled trial. Eligible and willing subjects will be randomly assigned to be treated with either H2M or placebo, in addition to standard treatments. The treatment with H2M or placebo will start as soon as possible after diagnosis of stroke, and continue for three days (hydrogen) and five days (minocycline) respectively. Measures of stroke severity and disability will be recorded at baseline, and through a follow-up phone call (45 days) and clinic visit (90 days).

Connect with a study center

  • Stony Brook University Hospital

    Stony Brook, New York 11794-8121
    United States

    Site Not Available

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