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NCT02178813 · ClinicalTrials.gov registry record · Phase 1
The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization
A Phase 1 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02178813 is a Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 6 participants.
The verdict
NCT02178813, a Phase 1 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline in the patient population undergoing carotid revascularization procedures, namely carotid endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will facilitate proceeding to a phase II trial. During this trial, patients undergoing carotid revascularization procedures will receive high doses of minocycline with the following schedule (based on previous trials): * Day prior to procedure: 800mg orally (p.o), 700mg p.o. * Day of procedure: 600mg intravenously( i.v.), 500mg p.o. * Day after procedure: 400mg p.o., 400mg p.o. The levels of the drug in the plasma, standard blood tests (complete blood count, creatinine, liver function tests) as well as markers of neuronal injury (Neuron specific enolase, protein- S100b) and inflammation (C-reactive protein) will also be monitored. The patients will be monitored closely for the development of side effects from minocycline. MRI imaging will be used to follow the development of small strokes as a result of the revascularization procedures and their resolution. The patients of this study, all receiving peri-operative minocycline, will be compared with historical controls with regards to development of small strokes and persistent of these strokes on subsequent MRI imaging.
Interventions
- DRUG Administration of minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02178813
The ClinicalTrials.gov registry entry for NCT02178813 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Administration of minocycline is the first listed.
NCT02178813 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02178813 about?
NCT02178813 is a clinical study titled "The Safety of High Dose Minocycline in the Patient Population Undergoing Carotid Revascularization". The purpose of this study is to evaluate the safety and tolerability of high-dose minocycline in the patient population undergoing carotid revascularization procedures, namely carotid endarterectomy (CEA) and carotid artery stenting (CAS). Establishment of safety will facilitate proceeding to a phas...
What is the current status of trial NCT02178813?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-07. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02178813?
The interventions under investigation include: Administration of minocycline (DRUG).
Who is sponsoring clinical trial NCT02178813?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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