Minocycline for Aneurysmal Subarachnoid Hemorrhage (MASH)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04876638 |
Recruitment Status :
Active, not recruiting
First Posted : May 6, 2021
Last Update Posted : February 10, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aneurysm, Ruptured Vasospasm, Intracranial Delayed Cerebral Ischemia Blood Brain Barrier Defect | Drug: Minocyclin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Minocycline as a Neuroprotective Agent Against Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | December 31, 2027 |
Estimated Study Completion Date : | December 30, 2028 |
- Drug: Minocyclin
10mg/kg minocycline up to 700mg for 4 days following aneurysmal subarachnoid hemorrhage
- Blood brain barrier permeability [ Time Frame: Measured by MRI permeability on post bleed day 5 ]
- Onset of cerebral vasospasm [ Time Frame: During 2 week vasospasm window following aneurysm rupture ]
- Serum MMP9 levels [ Time Frame: Measured baseline at time of enrollment and every other day until 14 days ]
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age of 18 to 85 years, ruptured cerebral aneurysm, enrolled within 24 hours of rupture
Exclusion Criteria:
- allergy to tetracycline, pregnancy, liver failure, kidney failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04876638
United States, California | |
University of Southern California Department of Neurosurgery | |
Los Angeles, California, United States, 90033 |
Responsible Party: | Jonathan Russin, Assistant Professor, University of Southern California |
ClinicalTrials.gov Identifier: | NCT04876638 |
Other Study ID Numbers: |
M.A.S.H. |
First Posted: | May 6, 2021 Key Record Dates |
Last Update Posted: | February 10, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Subarachnoid Hemorrhage Brain Ischemia Cerebral Infarction Vasospasm, Intracranial Aneurysm Aneurysm, Ruptured Hemorrhage Ischemia Pathologic Processes Vascular Diseases Cardiovascular Diseases Intracranial Hemorrhages |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Brain Infarction Stroke Infarction Necrosis Minocycline Anti-Bacterial Agents Anti-Infective Agents |