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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
H2M Trial Summary
This trialstudies a possible new treatment for stroke that combines two drugs to help improve neurological recovery.
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.Check my eligibility
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.See study design
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.
H2M Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Favorable Outcome on the Simplified Modified Rankin Scale (sMRSq)
Secondary outcome measures
NIH Stroke Scale (NIHSS)
Simplified Modified Rankin Scale (sMRSq)
H2M 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
2005
Completed Phase 4
~1000
Find a Location
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
214 Previous Clinical Trials
39,812 Total Patients Enrolled
1 Trials studying Ischemic Stroke
2,000 Patients Enrolled for Ischemic Stroke
Adrian Marchidann, MDPrincipal InvestigatorStony Brook University Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidneys are not working well, with a measured creatinine clearance below 30.You have a previous serious neurological disability and are unable to live independently.You recently had a severe stroke or have other serious health problems that might lead to death within the next 3 months.You have severe liver disease with more than three times the normal levels of certain liver enzymes or a significant decrease in liver function.You have a low number of platelets in your blood.You have an infectious disease that needs antibiotics which don't work well with minocycline.You are allergic to tetracycline drugs.You are currently taking retinoids or ergot alkaloids.You are not able to safely handle the amount of fluid (either through an IV or by drinking water) needed for the study medication.You are currently at Stony Brook University Hospital with a recent stroke caused by a lack of blood flow to the brain.You are 18 years old or older.Your stroke severity score at the beginning of the study is 5 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Hydrogen/Minocycline
- Group 2: Placebo Hydrogen/Placebo Minocycline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being monitored in this experiment?
"That is correct, according to the clinicaltrials.gov website this study is open for recruitment. The listing went up on 8/2/2017 with the most recent update being 11/14/2022. They are looking for a total of 100 patients from 1 location."
Answered by AI
Are there other instances of Hydrogen/Minocycliine being used in a medical context?
"As of now, there are 30 ongoing studies examining the effects of Hydrogen/Minocycliine. Of these 30 trials, 9 have progressed to Phase 3 testing. Most of the research being conducted for Hydrogen/Minocycliine is happening in Guangzhou, Guangdong; however, 525 different locations around the world are running clinical trials for this medication."
Answered by AI
Is this clinical trial looking for more participants?
"Yes, this information can be found on the clinicaltrials.gov website. The trial was first posted on 8/2/2017 and has since been updated on 11/14/2022."
Answered by AI
To what ailment is Hydrogen/Minocycliine most often applied?
"Rocky Mountain spotted fever is most commonly treated with the hydrogen/minocycliine drug cocktail. This treatment method is also effective for other conditions such as q fever, dental root planing, and respiratory tract infections."
Answered by AI
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