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NCT04876638 · ClinicalTrials.gov registry record · Phase 2
Minocycline for Aneurysmal Subarachnoid Hemorrhage (MASH)
A Phase 2 study of Delayed Cerebral Ischemia and Vasospasm, Intracranial, sponsored by University of Southern California.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04876638: Active Phase 2 study of Delayed Cerebral Ischemia and Vasospasm, Intracranial, sponsored by University of Southern California.
NCT04876638 is a Phase 2 study of Delayed Cerebral Ischemia and Vasospasm, Intracranial that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04876638, a Phase 2 study of Delayed Cerebral Ischemia and Vasospasm, Intracranial, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Previous work has demonstrated patients presenting with ruptured aneurysms that develop radiographic and clinical vasospasm have a higher permeability of the blood brain membrane. Matrix metalloproteinase 9 (MMP9) has been studied and recently implicated in both the pathogenesis of the blood brain barrier breakdown and vasogenic edema of ischemia strokes, and is suggested to be an accurate biomarker to predict the onset of cerebral vasospasm after subarachnoid hemorrhage. The therapeutic benefit of minocycline, an MMP9 inhibitor, has been investigated in ischemic stroke population, however its role in the treatment of cerebral vasospasm from ruptured aneurysms remains unknown. Our project has two main goals: to further confirm MMP9 has a reliable biomarker for the onset of cerebral vasospasm, and secondarily to investigate any possible therapeutic benefit that minocycline has in the vasospasm population. Vasospasm continues to be one of the major contributors of morbidity and mortality in the ruptured aneurysm population, and close monitoring of the neurologic exam during the 'vasospasm window' usually requires two weeks in the intensive care unit in most academic settings. As such, if we are better able to predict which patients are at risk of developing vasospasm based on MMP9 levels, we will be better able to anticipate the need for intervention and therefore mitigate the risk of vasospasm induced ischemic strokes, ultimately resulting in better outcomes in the ruptured aneurysm population. Further, if we are able to identify minocycline as a therapeutic agent to deter, or lessen the severity of vasospasm, we can possibly improve neurologic outcomes, decrease hospital stays, ultimately providing an improved and more cost-effective treatment strategy to our patients.
Conditions Studied
Interventions
- DRUG Minocyclin
Study Locations (1)
California
- University of Southern California Department of Neurosurgery - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 2 |
What the registry record for NCT04876638 still lists
NCT04876638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Delayed Cerebral Ischemia appearing as the primary indexed condition, and to 1 intervention - of which Minocyclin is the first listed.
NCT04876638 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04876638 about?
NCT04876638 is a clinical study titled "Minocycline for Aneurysmal Subarachnoid Hemorrhage (MASH)". Previous work has demonstrated patients presenting with ruptured aneurysms that develop radiographic and clinical vasospasm have a higher permeability of the blood brain membrane. Matrix metalloproteinase 9 (MMP9) has been studied and recently implicated in both the pathogenesis of the blood brain b...
What is the current status of trial NCT04876638?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-07-01. Estimated completion is 2028-12-30.
What conditions does trial NCT04876638 study?
This clinical trial studies the following conditions: Delayed Cerebral Ischemia, Vasospasm, Intracranial, Aneurysm, Ruptured, Blood Brain Barrier Defect.
What interventions are being tested in trial NCT04876638?
The interventions under investigation include: Minocyclin (DRUG).
Who is sponsoring clinical trial NCT04876638?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04876638 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04876638's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
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