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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: Completed Phase 1 study, sponsored by Wayne State University.
NCT01058395 is a Phase 1 study that has completed, run by Wayne State University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The main outcome measure after the safety data was the Disability Rating Scale (DRS). It is a 29 point scale with 29 being a severe vegetative state. It is reliable across time and demonstrates better sensitivity than the Glasgow Outcome Scale.It has been a standard primary outcome measure for most pharmaceutical studies for TBI, and was required by the FDA for the IND approval.
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-02 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT01058395 record still lists
NCT01058395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT01058395 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01058395's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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