Recruiting
Phase 3

Minocycline

Sponsor:

Rick Hansen Institute

Code:

NCT01828203

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Minocycline

Placebo

Surgical spinal cord decompression

Maintenance of minimum mean arterial pressure (MAP)

Study Details

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 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.

Conditions

Spinal Cord Injuries

Study ID

NCT01828203

Start date

Jun, 2013

Status verified date

Oct, 2014

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

248 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

placebo comparator: Placebo

250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days

Interventions

Minocycline

Placebo

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.

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.

Primary outcome measure

  • ASIA Motor Recovery [ Time Frame: assessed at time points: day 1,3,7, week 3,6, month 3,6,12 ]

Central Contacts and Locations

Central contacts

Steve Casha, MD PhD FRCSC

1-403-944-3405scasha@ucalgary.ca

John Hurlbert, MD PhD FRCSC FACS

1-403-944-4496jhurlber@ucalgary.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Steve Casha, MD PhD FRCSC

1-403-944-3405scasha@ucalgary.ca

John Hurlbert, MD PhD FRCSC FACS

1-403-944-4496jhurlber@ucalgary.ca

Principal Investigator:

Steve Casha, MD PhD FRCSC

University of Alberta & Royal Alexandra Hospitals

Recruiting

Edmonton, Alberta, Canada

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada

More Information

Sponsor

Rick Hansen Institute

Last update posted

Oct 30, 2014

Last verified

Oct, 2014

Keywords

  • minocycline
  • randomized control trial
  • phase 3
  • spinal cord injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rick Hansen Institute on 2014-10-30.