What side effects are associated with this type of intervention?

Common treatments for ischemic stroke include thrombolytics like tissue plasminogen activator (tPA), antiplatelet agents, and anticoagulants. Thrombolytics can cause bleeding complications, including intracerebral hemorrhage. Antiplatelet agents and anticoagulants can also increase the risk of bleeding. Neuroprotective treatments like minocycline, which is being studied for its antioxidant and anti-inflammatory properties, have shown potential in reducing infarction volume and neuroinflammation. Known side effects of minocycline include dizziness, nausea, and skin discoloration. Molecular hydrogen (H2) is being explored for its antioxidant effects, and while it is generally considered safe, more research is needed to fully understand its side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for ischemic stroke, primarily focusing on thrombolytic and anticoagulant therapies. Tissue plasminogen activator (tPA) is a well-known thrombolytic agent approved for acute ischemic stroke, which works by dissolving blood clots. Anticoagulants like warfarin and newer agents such as rivaroxaban are also used to prevent stroke in patients with atrial fibrillation. While the combination of molecular hydrogen H2 and minocycline is being studied for its antioxidant and neuroprotective effects, similar neuroprotective strategies have not yet been widely approved by the FDA for ischemic stroke. Current research is exploring these novel approaches to enhance recovery and reduce brain damage post-stroke.

What other types of research exist?

Promising novel alternatives for ischemic stroke treatment in 2024 include: 1) Edaravone, a free radical scavenger that has shown neuroprotective effects in stroke patients. 2) NXY-059, a nitrone-based free radical trapping agent that has demonstrated potential in reducing stroke-related damage. 3) Stem cell therapy, which aims to repair and regenerate damaged brain tissue. 4) Remote ischemic conditioning, a technique that induces brief, non-lethal ischemia in a limb to protect against stroke damage. These alternatives are under investigation and may offer new avenues for treatment.

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Other

Minocycline + Hydrogen for Stroke (H2M Trial)

Phase 2 & 3

Waitlist Available

Led By Adrian Marchidann, MD

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Summary

This trial tests a new treatment using hydrogen gas and an antibiotic to help protect the brain in stroke patients. The hydrogen reduces harmful substances, and the antibiotic blocks damaging processes. The goal is to see if this combination can improve recovery after a stroke. Hydrogen administration has shown neuroprotective effects in preclinical studies for neurological disorders including stroke.

Who is the study for?

Adults over 18 with acute ischemic stroke, able to receive treatment within 24 hours of the event, and a significant stroke severity (NIHSS ≥ 5). Not for pregnant or nursing women, those with severe pre-existing conditions, renal failure, liver disease, low platelets count, certain infections or allergies to tetracycline drugs.

What is being tested?

The trial is testing a new therapy combining molecular hydrogen H2 and minocycline ('H2M') against placebo treatments. It's designed to see if this combination can help neurological recovery after an acute ischemic stroke.

What are the potential side effects?

Potential side effects may include typical reactions associated with minocycline such as dizziness, fatigue, gastrointestinal issues like nausea or diarrhea; allergic reactions are possible in those sensitive to tetracycline antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Favorable Outcome on the Simplified Modified Rankin Scale (sMRSq)

Secondary study objectives

NIH Stroke Scale (NIHSS)

Simplified Modified Rankin Scale (sMRSq)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hydrogen/MinocyclineExperimental Treatment2 Interventions

Hydrogen will be infused into aqueous solution (normal saline or water) at as high a concentration as possible (saturation = 1.6 ppm), and administered intravenously or orally respectively, TID for 3 days. Similarly, Minocycline will be administered either i.v. or p.o. once daily for 5 days.

Group II: Placebo Hydrogen/Placebo MinocyclinePlacebo Group2 Interventions

Normal saline will be substituted for both Hydrogen and Minocycline for intravenous administration. Water will be substituted for hydrogen when administered p.o., and placebo capsules will be substituted for minocycline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrogen

2018

Completed Phase 3

~60

Minocycline

2019

Completed Phase 4

~1070

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ischemic stroke, such as Molecular Hydrogen H2 and Minocycline, focus on reducing oxidative stress and providing neuroprotection. Molecular Hydrogen H2 acts as an antioxidant, neutralizing harmful reactive oxygen species (ROS) generated during ischemia-reperfusion injury, thereby reducing cellular damage. Minocycline, an antibiotic with anti-inflammatory properties, inhibits microglial activation and reduces the release of pro-inflammatory cytokines, which helps in minimizing neuronal damage. These mechanisms are crucial for ischemic stroke patients as they help to preserve brain tissue, improve neurological outcomes, and enhance recovery by mitigating the secondary injury processes that exacerbate brain damage post-stroke.

Hydrogen-Rich Water Improves Cognitive Ability and Induces Antioxidative, Antiapoptotic, and Anti-Inflammatory Effects in an Acute Ischemia-Reperfusion Injury Mouse Model.

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Who is running the clinical trial?

Korea Institute of Science and TechnologyOTHER

6 Previous Clinical Trials

4,523 Total Patients Enrolled

Stony Brook UniversityLead Sponsor

222 Previous Clinical Trials

42,016 Total Patients Enrolled

2 Trials studying Ischemic Stroke

2,015 Patients Enrolled for Ischemic Stroke

Adrian Marchidann, MDPrincipal InvestigatorStony Brook University Hospital

Media Library

Hydrogen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03320018 — Phase 2 & 3

Ischemic Stroke Research Study Groups: Hydrogen/Minocycline, Placebo Hydrogen/Placebo Minocycline

Ischemic Stroke Clinical Trial 2023: Hydrogen Highlights & Side Effects. Trial Name: NCT03320018 — Phase 2 & 3

Hydrogen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03320018 — Phase 2 & 3

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