Minocycline in Acute Spinal Cord Injury (MASC)

Last updated: October 29, 2014
Sponsor: Rick Hansen Institute
Overall Status: Trial Status Unknown

Phase

3

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT01828203
RHI-1005
  • Ages > 16
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 16 or over

  • Acute traumatic non-penetrating cervical SCI involving neurological levels as definedby the ASIA neurological examination between C0 and C8 and resulting in a detectablechange 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 ofinjury.

Exclusion

Exclusion Criteria:

  • History of systemic lupus erythematosus (SLE)

  • 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 > 2times the upper limit of normal) at screening

  • Presence of systemic disease that might interfere with patient safety, compliance orevaluation of the condition under study (e.g. insulin-dependent diabetes, Lymedisease, clinically significant cardiac disease, HIV, HTLV-1)

  • Associated traumatic conditions interfering with informed consent or outcomeassessment (e.g. closed head injury, liver contusion)

  • Known uncorrected severe coronary artery disease or evidence of active coronaryischemia (ECG changes, positive Troponin) will be excluded, as they may not toleratethe standardized protocol for hemodynamic management

Study Design

Total Participants: 248
Study Start date:
June 01, 2013
Estimated Completion Date:
June 30, 2018

Connect with a study center

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • University of Alberta & Royal Alexandra Hospitals

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario
    Canada

    Active - Recruiting

  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario
    Canada

    Site Not Available

  • Hôpital Du Sacré-Cœur de Montréal

    Montreal, Quebec
    Canada

    Site Not Available

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