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Neuroprotection in Acute Ischemic Stroke (H2M)

Primary Purpose

Stroke, Ischemic

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hydrogen

Minocycline

Placebo Hydrogen

Placebo Minocycline

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring neuroprotection, antioxidant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

1. 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 < 30 5. Liver disease leading to > 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.

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 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*

Sites / Locations

Stony Brook University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrogen/Minocycline

Placebo Hydrogen/Placebo Minocycline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

simplified modified Rankin Scale (sMRSq)

rating scale to assess level of functional independence for patients post-stroke. Scores range from 0 (no symptoms) to 6 (dead).

Secondary Outcome Measures

simplified modified Rankin Scale (sMRSq)

rating scale to assess level of functional independence for patients post-stroke. Scores range from 0 (no symptoms) to 6 (dead).

NIH Stroke Scale (NIHSS)

15-item neurologic examination scale for severity of stroke. Ratings for each item are scored with 3 to 5 grades. A total NIHSS of 0 is normal; 1-4 is considered a minor stroke; 5-15 moderate; 16-20 moderate to severe; and 21-42 severe.

Full Information

NCT ID

NCT03320018

First Posted

October 20, 2017

Last Updated

November 14, 2022

Sponsor

Stony Brook University

1. Study Identification

Unique Protocol Identification Number

NCT03320018

Brief Title

Neuroprotection in Acute Ischemic Stroke

Acronym

H2M

Official Title

Pilot Study of the Neuroprotective Effects of Hydrogen and Minocycline in Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 2, 2017 (Actual)

Primary Completion Date

November 2, 2024 (Anticipated)

Study Completion Date

November 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic

Keywords

neuroprotection, antioxidant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydrogen/Minocycline

Arm Type

Experimental

Arm Description

Arm Title

Placebo Hydrogen/Placebo Minocycline

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Hydrogen

Other Intervention Name(s)

Intervention Description

Hydrogen will be infused into bags of normal saline solution and administered intravenously, or hydrogen generating tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days.

Intervention Type

Drug

Intervention Name(s)

Minocycline

Other Intervention Name(s)

Minocin, Minomycin, Akamin

Intervention Description

Minocycline 200 mg will be mixed with normal saline and given by i.v. administration, or provided as capsules for the patient to swallow, q 24 hours for 5 days. Once patients regain the ability to swallow capsules, minocycline will be given orally in capsule form (2 capsules of 100 mg each), administered once daily for the remainder of the 5 day period.

Intervention Type

Other

Intervention Name(s)

Placebo Hydrogen

Intervention Description

Normal saline solution will be administered intravenously, in place of hydrogen solution. Placebo tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days.

Intervention Type

Other

Intervention Name(s)

Placebo Minocycline

Intervention Description

Normal saline solution or placebo capsule will be administered i.v. or p.o. respectively, in place of minocycline.

Primary Outcome Measure Information:

Title

simplified modified Rankin Scale (sMRSq)

Description

rating scale to assess level of functional independence for patients post-stroke. Scores range from 0 (no symptoms) to 6 (dead).

Time Frame

90 days

Secondary Outcome Measure Information:

Title

simplified modified Rankin Scale (sMRSq)

Description

rating scale to assess level of functional independence for patients post-stroke. Scores range from 0 (no symptoms) to 6 (dead).

Time Frame

45 days

Title

NIH Stroke Scale (NIHSS)

Description

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 1. 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 < 30 5. Liver disease leading to > 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. 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 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*

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Pol

Phone

631-444-9083

christiana.pol@stonybrookmedicine.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kamil Stefanowski, MD

kamil.stefanowski@stonybrookmedicine.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis Choi, MD, PhD

Organizational Affiliation

Stony Brook University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Stony Brook University Hospital

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-8121

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Pol, PhD

Phone

631-444-9083

christiana.pol@stonybrookmedicine.edu

First Name & Middle Initial & Last Name & Degree

Kamil Stefanowski, MD

kamil.stefanowski@stonybrookmedicine.edu

12. IPD Sharing Statement

Plan to Share IPD

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