Spinal Cord Injuries Clinical Trial
Official title:
Phase III Study of Minocycline in Acute Spinal Cord Injury
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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