We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minocycline in Acute Spinal Cord Injury (MASC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01828203
Recruitment Status : Recruiting
First Posted : April 10, 2013
Last Update Posted : October 30, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

April 5, 2013
April 10, 2013
October 30, 2014
June 2013
June 2018   (Final data collection date for primary outcome measure)
ASIA Motor Recovery [ Time Frame: assessed at time points: day 1,3,7, week 3,6, month 3,6,12 ]
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.
ASIA Motor Recovery [ Time Frame: day 1,3,7, week 3,6, month 3,6,12 ]
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.
Complete list of historical versions of study NCT01828203 on ClinicalTrials.gov Archive Site
  • ASIA sensory recovery [ Time Frame: assessed at time points: day 1,3,7 week 3,6, months 3,6,12 ]
    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 ]
    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 ]
    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 ]
    change in ASIA impairment grade at specified time points
  • ASIA sensory recovery [ Time Frame: day 1,3,7 week 3,6, months 3,6,12 ]
    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: week 6, month 3,6,12 ]
    Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points.
  • Short Form 36 (SF-36) [ Time Frame: week 6, month 3,6,12 ]
    functional outcome as assessed by the short form 36 (SF-36) quality of Life assessment at specified time points.
  • ASIA impairment grade [ Time Frame: day 1,3,7 week 3,6 month 3,6,12 ]
    change in ASIA impairment grade at specified time points
effect of injury severity [ Time Frame: as per primary and secondary outcomes ]
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
Same as current
 
Minocycline in Acute Spinal Cord Injury (MASC)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injuries
  • Drug: Minocycline
  • 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.
  • 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
    Interventions:
    • Drug: Minocycline
    • Procedure: Surgical spinal cord decompression
    • Procedure: Maintenance of minimum mean arterial pressure (MAP)
  • Placebo Comparator: Placebo
    250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days
    Interventions:
    • Drug: Placebo
    • Procedure: Surgical spinal cord decompression
    • Procedure: Maintenance of minimum mean arterial pressure (MAP)
Casha S, Zygun D, McGowan MD, Bains I, Yong VW, Hurlbert RJ. Results of a phase II placebo-controlled randomized trial of minocycline in acute spinal cord injury. Brain. 2012 Apr;135(Pt 4):1224-36. doi: 10.1093/brain/aws072.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
248
June 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
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
Australia,   Canada
 
 
NCT01828203
RHI-1005
Yes
Not Provided
Not Provided
Steve Casha, University of Calgary
Rick Hansen Institute
  • University of Calgary
  • Alberta Paraplegic foundation
Principal Investigator: Steve Casha, MD PhD FRCSC University of Calgary
Rick Hansen Institute
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP