Skip to main content
OpenTrials
Completed

NCT Number: NCT00559494

Minocycline and Perfusion Pressure Augmentation in Acute Spinal Cord Injury

While research in animal models of spinal cord injury have provided many promising insights, human studies have failed to produce effective therapies. We propose to investigate the drug Minocycline (a metalloproteinase inhibitor) for the treatment of spinal cord injured patients aiming to limit neurological injury and improve neurological outcome. This drug influences several secondary injury mechanisms implicated in spinal cord injury and has been effective in improving outcome after spinal cord injury in animal models. We also propose to examine the safety and feasibility of spinal cord perfusion pressure augmentation with a protocol of IV fluids and inotrope medications versus standard maintenance of mean arterial pressure in subjects who exhibit a decrease in perfusion pressure to less than 75 mmHg. The purpose of this pilot study is 1) to evaluate the feasibility of a clinical trial protocol for Minocycline in patients with acute spinal cord injury, and 2) to ensure adequate drug dosing and metabolic effect. After undergoing a process of informed consent, patients agreeing to participate in the study will be randomized to placebo or treatment groups in a double-blind fashion. Clinical neurological examinations, patient-reported quality of life, and functional independence categorization will be combined with serum and cerebrospinal fluid laboratory investigations to establish some of the pharmacological properties and the safety profile of this medication in this group of patients. In addition, patient tolerance to the dosing regimen will be assessed. The results of this study will provide the preliminary data necessary to plan for a larger prospective, randomized, controlled, double-blind clinical trial to assess efficacy and to further assess safety.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 16 or over
  • Motor complete or motor incomplete acute spinal cord injury involving bony spinal levels between C0 and T11
  • Patient able to provide informed consent
  • Randomization and commencement of administration of first drug dose within 12 hours of injury
  • surgical decompression if needed to be performed within 24 hours of the injury
  • subjects exhibiting spinal cord perfusion pressure (lumbar drain transduced pressure - mean arterial pressure)> 75 mmHg will be randomized to active augmentation protocol versus maintenance of mean arterial pressure

Exclusion criteria

  • Acute spinal cord injury >12 hours old
  • Isolated sensory deficit, motor intact
  • Isolated cauda equina injury or injury at bony level T12 or below
  • History of systemic lupus erythematosus (SLE)
  • Pre-existing hepatic or renal disease
  • Tetracycline hypersensitivity
  • Pregnancy or breast feeding
  • Isolated sensory deficit
  • Isolated radicular motor deficit
  • Significant leukopenia (white blood cell count < ½ 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 from SCPP randomization

Treatment and study plan

Minocycline

Drug

Minocycline IV BID x 7 days (first 10 patients 200 mg/dose, subsequent patients adjusted based on pharmacodynamic profiling to 800 mg loading dose, tapered 100 mg each dose to 400 mg then maintain at 400mg until day 7)

Other names: Minocin

Placebo

Drug

Normal saline 250cc via central line similar to minocycline arm administration protocol

Other names: control, saline

SCPP augmentation

Procedure

maintenance of spinal cord perfusion pressure at 75 mmHg with fluids and inotrope protocol

SCPP control

Procedure

maintenance of Mean arterial pressure of >65 mmHg with fluids and inotropes protocol without spinal cord perfusion pressure as target or guiding therapy

Primary outcomes

  1. Protocol compliance, feasibility and adverse events

    Time frame: 2 years

Secondary outcomes

  1. American Spinal Injury Association - motor score (primary clinical outcome) and sensory scores

    Time frame: 2 years

  2. Short Form 36 - Quality of Life Assessment

    Time frame: 2 years

  3. Functional Independence Measure

    Time frame: 2 years

  4. London Handicap Scale

    Time frame: 2 years

  5. Spinal Cord Injury Measure

    Time frame: 2 years

  6. CSF collection (6/day) and biochemical assays

    Time frame: 7 days

  7. Sequential Anatomical MRI

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • American Association of Neurological Surgeons
  • Hotchkiss Brain Institute, University of Calgary
  • Paralyzed Veterans of America

Registry information

Official study title

A Pilot Study to Assess Clinical Safety and Tolerance of Minocycline and Spinal Perfusion Pressure Augmentation in Acute Spinal Cord Injury

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2007
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.