Phase 3 N=14 Randomized Triple-blind Treatment

Neuroprotection in Acute Ischemic Stroke

Stroke, Ischemic

Bottom Line

View on ClinicalTrials.gov: NCT03320018 ↗

Enrolled (actual)

Serious AEs

21.4%

Results posted

Dec 2023

Primary outcome: Primary: Number of Participants With Favorable Outcome on the Simplified Modified Rankin Scale (sMRSq) — 5; 7; 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Hydrogen (Drug); Minocycline (Drug); Placebo Hydrogen (Other); Placebo Minocycline (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stony Brook University
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Favorable Outcome on the Simplified Modified Rankin Scale (sMRSq)	5; 7; 1; 1	—
SECONDARY Simplified Modified Rankin Scale (sMRSq)	2.8; 3.4	—
SECONDARY NIH Stroke Scale (NIHSS)	4; 7.5	—

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 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 Criteria

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 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.
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*

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03320018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.