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Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)

NCT01058395 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-09-17

Study results available
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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.

Conditions

Interventions

DRUG

Minocycline

Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days.

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Jay M Meythaler, MD · Wayne State University

  • Kristina Freese, PA · Wayne State University Dept. PM&R Oakwood

  • John Fath, MD · Oakwood Hospital Dearborn, Trauma Surgery Director

  • Allen Lamb, DO · Oakwood Southshore Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-09-30
Completion
2016-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058395 on ClinicalTrials.gov