Status:
UNKNOWN
Minocycline in Acute Spinal Cord Injury (MASC)
Lead Sponsor:
Rick Hansen Institute
Collaborating Sponsors:
University of Calgary
Alberta Paraplegic foundation
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 hy...
Eligibility Criteria
Inclusion
- Age 16 or over
- 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
- 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 \> 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT01828203
Start Date
June 1 2013
End Date
June 1 2018
Last Update
October 30 2014
Active Locations (7)
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1
Princess Alexandra Hospital
Brisbane, Queensland, Australia
2
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
3
University of Alberta & Royal Alexandra Hospitals
Edmonton, Alberta, Canada
4
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada