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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03320018 |
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Date of registration:
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20/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neuroprotection in Acute Ischemic Stroke
H2M |
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Scientific title:
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Pilot Study of the Neuroprotective Effects of Hydrogen and Minocycline in Acute Ischemic Stroke |
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Date of first enrolment:
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August 2, 2017 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03320018 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Dennis Choi, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stony Brook University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Aged 18 years old or over
2. Presenting to/at Stony Brook University Hospital with acute ischemic stroke
3. Baseline (at admission to study) National Institute of Health Stroke Scale (NIHSS) of
= 5
4. 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*
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke, Ischemic
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Intervention(s)
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Drug: Minocycline
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Drug: Hydrogen
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Other: Placebo Hydrogen
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Other: Placebo Minocycline
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Primary Outcome(s)
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Number of Participants With Favorable Outcome on the Simplified Modified Rankin Scale (sMRSq)
[Time Frame: 90 days]
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Secondary Outcome(s)
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NIH Stroke Scale (NIHSS)
[Time Frame: 90 days]
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Simplified Modified Rankin Scale (sMRSq)
[Time Frame: 45 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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