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Trial record 17 of 548 for:    "Spinal Cord Injuries"

Minocycline in Acute Spinal Cord Injury (MASC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Rick Hansen Institute Canada Inc.
Sponsor:
Collaborators:
University of Calgary
Alberta Paraplegic foundation
Information provided by (Responsible Party):
Steve Casha, University of Calgary
ClinicalTrials.gov Identifier:
NCT01828203
First received: April 5, 2013
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Drug: Minocycline
Drug: Placebo
Procedure: Surgical spinal cord decompression
Procedure: Maintenance of minimum mean arterial pressure (MAP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Minocycline in Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Rick Hansen Institute Canada Inc.:

Primary Outcome Measures:
  • ASIA Motor Recovery [ Time Frame: assessed at time points: day 1,3,7, week 3,6, month 3,6,12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • ASIA sensory recovery [ Time Frame: assessed at time points: day 1,3,7 week 3,6, months 3,6,12 ] [ Designated as safety issue: No ]
    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

  • Spinal cord Independence measure (SCIM) [ Time Frame: assessed at time points: week 6, month 3,6,12 ] [ Designated as safety issue: No ]
    Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points.

  • Short Form 36 (SF-36) [ Time Frame: assessed at time points: week 6, month 3,6,12 ] [ Designated as safety issue: No ]
    functional outcome as assessed by the short form 36 (SF-36) quality of Life assessment at specified time points.

  • ASIA impairment grade [ Time Frame: assessed at time points: day 1,3,7 week 3,6 month 3,6,12 ] [ Designated as safety issue: No ]
    change in ASIA impairment grade at specified time points


Other Outcome Measures:
  • effect of injury severity [ Time Frame: as per primary and secondary outcomes ] [ Designated as safety issue: No ]
    the sub groups of motor complete (ASIA A and B) and motor incomplete (ASIA C and D) will be examines for each of the primary and secondary outcomes in order to examine the relative efficacy of minocycline in these groups


Estimated Enrollment: 248
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Minocycline Procedure: 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.
Procedure: 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 Comparator: Placebo
250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days
Drug: Placebo Procedure: 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.
Procedure: 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 > 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828203

Contacts
Contact: Steve Casha, MD PhD FRCSC 1-403-944-3405 scasha@ucalgary.ca
Contact: John Hurlbert, MD PhD FRCSC FACS 1-403-944-4496 jhurlber@ucalgary.ca

Locations
Australia, Queensland
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia
Contact: Michael Schuetz, MD         
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Steve Casha, MD PhD FRCSC    1-403-944-3405    scasha@ucalgary.ca   
Contact: John Hurlbert, MD PhD FRCSC FACS    1-403-944-4496    jhurlber@ucalgary.ca   
Principal Investigator: Steve Casha, MD PhD FRCSC         
Sub-Investigator: John Hurlbert, MD PhD FRCSC FACS         
Sub-Investigator: Bradley Jacobs, MD FRCSC         
University of Alberta & Royal Alexandra Hospitals Recruiting
Edmonton, Alberta, Canada
Contact: Andrew Nataraj, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Sean Christie, MD         
Canada, Ontario
London Health Sciences Centre - Victoria Hospital Recruiting
London, Ontario, Canada
Contact: Chris Bailey, MD         
The Ottawa Hospital - Civic Campus Not yet recruiting
Ottawa, Ontario, Canada
Contact: Eve Tsai, MD         
Canada, Quebec
Hôpital Du Sacré-Cœur de Montréal Not yet recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Rick Hansen Institute Canada Inc.
University of Calgary
Alberta Paraplegic foundation
Investigators
Principal Investigator: Steve Casha, MD PhD FRCSC University of Calgary
  More Information

Publications:
Responsible Party: Steve Casha, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01828203     History of Changes
Other Study ID Numbers: RHI-1005
Study First Received: April 5, 2013
Last Updated: October 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by Rick Hansen Institute Canada Inc.:
minocycline
randomized control trial
phase 3
spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014