Minocycline and Perfusion Pressure Augmentation in Acute Spinal Cord Injury
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
While research in animal models of spinal cord injury have provided many promising insights,
human studies have failed to produce effective therapies. We propose to investigate the drug
Minocycline (a metalloproteinase inhibitor) for the treatment of spinal cord injured patients
aiming to limit neurological injury and improve neurological outcome. This drug influences
several secondary injury mechanisms implicated in spinal cord injury and has been effective
in improving outcome after spinal cord injury in animal models. We also propose to examine
the safety and feasibility of spinal cord perfusion pressure augmentation with a protocol of
IV fluids and inotrope medications versus standard maintenance of mean arterial pressure in
subjects who exhibit a decrease in perfusion pressure to less than 75 mmHg. The purpose of
this pilot study is 1) to evaluate the feasibility of a clinical trial protocol for
Minocycline in patients with acute spinal cord injury, and 2) to ensure adequate drug dosing
and metabolic effect. After undergoing a process of informed consent, patients agreeing to
participate in the study will be randomized to placebo or treatment groups in a double-blind
fashion. Clinical neurological examinations, patient-reported quality of life, and functional
independence categorization will be combined with serum and cerebrospinal fluid laboratory
investigations to establish some of the pharmacological properties and the safety profile of
this medication in this group of patients. In addition, patient tolerance to the dosing
regimen will be assessed. The results of this study will provide the preliminary data
necessary to plan for a larger prospective, randomized, controlled, double-blind clinical
trial to assess efficacy and to further assess safety.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Calgary
Collaborators:
American Association of Neurological Surgeons Hotchkiss Brain Institute, University of Calgary Paralyzed Veterans of America