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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01058395
• Date of registration: 19/01/2010
• Primary sponsor: Wayne State University
• Public title: Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI) TBI
• Scientific title: Phase I Study of Minocycline in a Dose Escalation Study as a Safe, Efficacious Therapeutic Intervention for Moderate and Severe TBI in Humans
• Date of first enrolment: February 2010
• Target sample size: 14
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01058395
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jay M Meythaler, MD

• Name: John Fath, MD
• Affiliation: Oakwood Hospital Dearborn, Trauma Surgery Director

• Name: Jay M Meythaler, MD
• Affiliation: Wayne State University

• Name: Kristina Freese, PA
• Affiliation: Wayne State University Dept. PM&R Oakwood

• Name: Robert Welch, MD
• Affiliation: Wayne State University, Detroit Receiving Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male , 18 to 75 years of age, irrespective of race;

- Ability to provide written informed consent or have legal representative provide
written informed consent;

- Must be enrolled in the study within 6 of injury and meet the following criteria:

- GCS score of 12 or less within the first 4 hours of injury;

- Evidence of neurological injury on computer tomography (CT) of the head;

- No known allergy to minocycline or other contraindication to receiving this
medication.

- Presence of central venous catheter;

- Participants must not have a known life-threatening disease prior to the brain
injury: However, individuals with a stable medical illness in the opinion of the
investigator may be allowed to enter the study;

- Participants are not to be on any other interventional studies aimed at enhancing
neurorecovery;

- Participants are not to be receiving immunosuppressant agents prior to study
enrollment.

Exclusion Criteria:

- Participant is a female;

- Participants, guardians or legal representatives who are unwilling to cooperate with
the investigation;

- Participants who have received any other investigational drug within 30 days of
injury;

- Participants known to have severe ischemic heart disease or congestive heart failure,
myocardial infarction, spinal cord injury with ongoing deficits, cancer or any other
severe illnesses that in the opinion of the investigator would affect the assessment
of therapy;

- Participants with an ongoing neurological disease/condition or previous stroke or
TBI;

- Known clinical sequelae of spinal cord injury;

- Massive cerebral hemisphere or brainstem hematoma, incompatible with survival;

- History of major depression requiring the use of the medication at the time of
injury;

- Multiple trauma which in the opinion of the investigator, would jeopardize the
assessment of therapy;

- Participants who have any type of penetrating head injury;

- Participants receiving chronic steroid treatment;

- Participants receiving isotretinoin;

- Lack of informed consent signed by either the participant or the subject's legal
representative;

- Prior TBI, brain tumor, cerebral vascular event, or other stable brain insult;

- Prior history of Pseudotumor cerebri ;

- Patients with known renal failure, BUN/ Creatinine 20:1; creatinine > 2 mg/dl;

- Patients with known hepatic failure, AST/ALT> 3 x Upper Limit of Normal;

- Thrombocytopenia < 75,000/mm;

- Known allergy or sensitivity to any of the tetracyclines or any of the components of
the product formulation.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Traumatic Brain Injury

Intervention(s)

Drug: Minocycline

Primary Outcome(s)

Disability Rating Scale [Time Frame: 3 months]

Drug levels, toxicity. [Time Frame: 7 days]

Secondary Outcome(s)

Liver enzymes and white-blood cell counts along with appropriate microbiologic cultures, Disability Rating Scale (DRS), Symbol Digit Modalities Test (SDMT), California Verbal Learning Test - 2nd Edition, Trails B, and SF-12 [Time Frame: 7 days, 3 months]

Secondary ID(s)

#H133A080044 -01

IND# 104298

Source(s) of Monetary Support

Please refer to primary and secondary sponsors