The objective of this study is to assess the efficacy of IV minocycline in improving neurological and functional outcome after acute non-penetrating traumatic spinal cord injury (SCI). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
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.
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.
Princess Alexandra Hospital
Brisbane, Queensland, Australia
RECRUITINGFoothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGUniversity of Alberta & Royal Alexandra Hospitals
Edmonton, Alberta, Canada
RECRUITINGQueen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
NOT_YET_RECRUITINGLondon Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
RECRUITINGThe Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGHôpital Du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
NOT_YET_RECRUITINGASIA Motor Recovery
Motor recovery (improvement from baseline examination) 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.
Time frame: assessed at time points: day 1,3,7, week 3,6, month 3,6,12
ASIA sensory recovery
Sensory recovery (improvement from baseline) 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
Time frame: assessed at time points: day 1,3,7 week 3,6, months 3,6,12
Spinal cord Independence measure (SCIM)
Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points.
Time frame: assessed at time points: week 6, month 3,6,12
Short Form 36 (SF-36)
functional outcome as assessed by the short form 36 (SF-36) quality of Life assessment at specified time points.
Time frame: assessed at time points: week 6, month 3,6,12
ASIA impairment grade
change in ASIA impairment grade at specified time points
Time frame: assessed at time points: day 1,3,7 week 3,6 month 3,6,12
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