Neuroprotection in Acute Ischemic Stroke

• Status: Unknown status
• Trial end date: 2020-11-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Collaborator: Korea Institute of Science and Technology
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. Aged 18 years old or over

2. Presenting to/at SBUH with acute ischemic stroke

3. Baseline (at admission to study) National Institute of Health Stroke Scale (NIHSS) between 5-22 inclusive

4. Administration of study medication possible within 24 hours of last known well -

Exclusion Criteria:

1. Other major diseases of the central nervous system, including brain tumors, Alzheimer's disease, Parkinson's disease, demyelinating disease, inflammatory brain or vascular disease, craniotomy, traumatic encephalopathy, or idiopathic intracranial hypertension*

2. Pre-existing neurological disability (historical NIHSS > 0); 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 > 2x elevation in liver transaminases or significant loss of synthetic capacity*

6. Thrombocytopenia (<100x109platelets / L blood)

7. Pre-existing infectious disease requiring antibiotic therapy

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 NS 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*