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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: Clinical Trial Phase 1 study, sponsored by University of Pittsburgh.
NCT02178813 is a Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary aim of this phase I study is to establish the safety and tolerability of this drug in patient population undergoing carotid revascularization procedures by monitoring complete blood counts, liver enzymes, renal function tests, and clinical side effects During the above time frame (one day prior to procedure until 1 day after the procedure) the number of patients that develop any side effects requiring discontinuation of the drug will be noted. Side effects that will lead to discont
Interventions
- DRUG Administration of minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
Why NCT02178813 stopped before completion
NCT02178813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Administration of minocycline is the first listed.
NCT02178813 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02178813's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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