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NCT01058395 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)
A Phase 1 study, sponsored by Wayne State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01058395 is a Phase 1 study that has completed, run by Wayne State University. The registered enrollment target is 15 participants.
The verdict
NCT01058395, a Phase 1 study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is: 1. To assess the safety and feasibility of minocycline administration after TBI in a dose escalation study at two different doses over 7 days. 2. To assess the pharmacokinetic characteristics of two different dosing regimens of minocycline in TBI patients, the effect on biochemical markers of neuroprotective mechanisms, and effect on neurobehavioral and functional outcome. 3. To begin initial assessment of the efficacy of minocycline as a therapeutic agent for severe human TBI.
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-02 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01058395
The ClinicalTrials.gov registry entry for NCT01058395 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT01058395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01058395 about?
NCT01058395 is a clinical study titled "Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)". The purpose of this study is: 1. To assess the safety and feasibility of minocycline administration after TBI in a dose escalation study at two different doses over 7 days. 2. To assess the pharmacokinetic characteristics of two different dosing regimens of minocycline in TBI patients, the effect o...
What is the current status of trial NCT01058395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-02. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01058395?
The interventions under investigation include: Minocycline (DRUG).
Who is sponsoring clinical trial NCT01058395?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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