Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
248 participants
INTERVENTIONAL
2013-06-30
2018-06-30
Brief Summary
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The primary hypothesis is that intravenous minocycline twice daily (800 mg initial dose tapered to 400 mg by 100 mg at each dose then administered to the end of day 7) administered to subjects with acute traumatic non-penetrating cervical SCI starting within 12 hours of injury will improve motor recovery as assessed by the International Standards for Neurologic Classification of Spinal Cord Injury - ISNCSCI (a.k.a. ASIA) neurological examination measured between 3 months and 1 year post-injury, compared to placebo.
The secondary hypotheses are that the above minocycline treatment will also results in improvement in ASIA sensory improvement, in ASIA grade and in functional outcome as assessed by Spinal Cord Independence Measure (SCIM) and Short Form 36 (SF-36), compared to placebo. In addition the effect of minocycline on neurological and functional outcome after SCI is expected to be more pronounced in those subjects with motor incomplete SCI compared to those with motor compete SCI. A subgroup analysis will be undertaken to examine this hypothesis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Minocycline
Minocycline twice daily infused over 30 minutes through central venous access as follows 800 mg + 700 mg on Day 1, 600 mg + 500 mg on Day 2, and 400 mg thereafter from Day 3 thru Day 7
Minocycline
Surgical spinal cord decompression
Surgical decompression by means at the discretion of the clinical management team will occur within 24 hours of injury in all subjects. Stabilization will occur at that time but may also include further interventions at a later time.
Maintenance of minimum mean arterial pressure (MAP)
Standardized hemodynamic management protocol aimed at maintaining MAP ≥ 85 mm Hg for 7 days using volume augmentation with isotonic crystalloid followed by inotropic support if needed will be applied to all subjects.
Placebo
250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days
Placebo
Surgical spinal cord decompression
Surgical decompression by means at the discretion of the clinical management team will occur within 24 hours of injury in all subjects. Stabilization will occur at that time but may also include further interventions at a later time.
Maintenance of minimum mean arterial pressure (MAP)
Standardized hemodynamic management protocol aimed at maintaining MAP ≥ 85 mm Hg for 7 days using volume augmentation with isotonic crystalloid followed by inotropic support if needed will be applied to all subjects.
Interventions
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Minocycline
Placebo
Surgical spinal cord decompression
Surgical decompression by means at the discretion of the clinical management team will occur within 24 hours of injury in all subjects. Stabilization will occur at that time but may also include further interventions at a later time.
Maintenance of minimum mean arterial pressure (MAP)
Standardized hemodynamic management protocol aimed at maintaining MAP ≥ 85 mm Hg for 7 days using volume augmentation with isotonic crystalloid followed by inotropic support if needed will be applied to all subjects.
Eligibility Criteria
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Inclusion Criteria
* Acute traumatic non-penetrating cervical SCI involving neurological levels as defined by the ASIA neurological examination between C0 and C8 and resulting in a detectable change in the ASIA motor assessment
* Patient English speaking and able to provide informed consent
* Randomization and administration of first dose (drug or placebo) within 12 hours of injury.
Exclusion Criteria
* Pre-existing hepatic or renal disease
* Tetracycline hypersensitivity
* Pregnancy or breast feeding
* Isolated radicular motor deficit
* Significant leucopenia (white blood cell count \< 1⁄2 times the lower limit of normal) at screening
* Elevated liver function tests (AST, ALT, alkaline phosphatase, or total bilirubin \> 2 times the upper limit of normal) at screening
* Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1)
* Associated traumatic conditions interfering with informed consent or outcome assessment (e.g. closed head injury, liver contusion)
* Known uncorrected severe coronary artery disease or evidence of active coronary ischemia (ECG changes, positive Troponin) will be excluded, as they may not tolerate the standardized protocol for hemodynamic management
16 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Alberta Paraplegic foundation
UNKNOWN
Rick Hansen Institute
OTHER
Responsible Party
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Steve Casha
Associate Professor
Principal Investigators
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Steve Casha, MD PhD FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Princess Alexandra Hospital
Brisbane, Queensland, Australia
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta & Royal Alexandra Hospitals
Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Hôpital Du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Michael Schuetz, MD
Role: primary
Andrew Nataraj, MD
Role: primary
Sean Christie, MD
Role: primary
Chris Bailey, MD
Role: primary
Eve Tsai, MD
Role: primary
References
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Casha S, Zygun D, McGowan MD, Bains I, Yong VW, Hurlbert RJ. Results of a phase II placebo-controlled randomized trial of minocycline in acute spinal cord injury. Brain. 2012 Apr;135(Pt 4):1224-36. doi: 10.1093/brain/aws072.
Other Identifiers
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RHI-1005
Identifier Type: -
Identifier Source: org_study_id
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