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Sponsors and Collaborators: |
University of Calgary Paralyzed Veterans of America American Association of Neurological Surgeons Hotchkiss Brain Institute, University of Calgary |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00559494 |
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.
Condition | Intervention | Phase |
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Spinal Cord Injuries |
Drug: Minocycline Drug: placebo Procedure: SCPP augmentation Procedure: SCPP control |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study to Assess Clinical Safety and Tolerance of Minocycline and Spinal Perfusion Pressure Augmentation in Acute Spinal Cord Injury |
Estimated Enrollment: | 60 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Minocycline: Experimental |
Drug: Minocycline
Minocycline IV BID x 7 days (first 10 patients 200 mg/dose, subsequent patients adjusted based on pharmacodynamic profiling to 800 mg loading dose, tapered 100 mg each dose to 400 mg then maintain at 400mg until day 7)
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Placebo: Placebo Comparator |
Drug: placebo
Normal saline 250cc via central line similar to minocycline arm administration protocol
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SCPP augmentation: Experimental |
Procedure: SCPP augmentation
maintenance of spinal cord perfusion pressure at 75 mmHg with fluids and inotrope protocol
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SCPP control: Sham Comparator |
Procedure: SCPP control
maintenance of Mean arterial pressure of >65 mmHg with fluids and inotropes protocol without spinal cord perfusion pressure as target or guiding therapy
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven Casha, MD PhD | 403 944 3405 | scasha@ucalgary.ca |
Contact: R. John Hurlbert, MD PhD | 403 944 4496 | jhurlber@ucalgary.ca |
Canada, Alberta | |
Foothills Medical Centre | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Steven Casha, MD PhD FRCSC 403 944 3405 scasha@ucalgary.ca | |
Principal Investigator: Steven Casha, MD PhD FRCSC |
Principal Investigator: | Steven Casha, MD PhD FRCSC | University of Calgary |
Principal Investigator: | R. John Hurlbert, MD PhD FRCSC | University of Calgary |
Principal Investigator: | David Zygun, MD MSc | University of Calgary |
Responsible Party: | University of Calgary ( S Casha and RJ Hurlbert ) |
Study ID Numbers: | 17007, PVA2414 |
Study First Received: | November 14, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00559494 |
Health Authority: | Canada: Health Canada |
complete spinal cord injury incomplete spinal cord injury central cord spinal cord injury traumatic |
Spinal Cord Injuries Minocycline Spinal Cord Diseases Benzocaine |
Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Nervous System Diseases Pharmacologic Actions |