Suspended

Phase III Study of Minocycline in Acute Spinal Cord Injury

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What is being tested

Minocycline

+ Surgical spinal cord decompression

+ Maintenance of minimum mean arterial pressure (MAP)

DrugProcedure
Who is being recruted

Central Nervous System Diseases+3

+ Nervous System Diseases

+ Spinal Cord Diseases

Over 16 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorRick Hansen Institute
Study ContactSteve Casha, MD PhD FRCSCMore contacts
Last updated: October 30, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01828203
Principal SponsorRick Hansen Institute
Study ContactSteve Casha, MD PhD FRCSCMore contacts
Last updated: October 30, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

248 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesWounds and InjuriesTrauma, Nervous SystemSpinal Cord Injuries

Criteria

4 inclusion criteria required to participate
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
Age 16 or over
Patient English speaking and able to provide informed consent
Randomization and administration of first dose (drug or placebo) within 12 hours of injury
10 exclusion criteria prevent from participating
Associated traumatic conditions interfering with informed consent or outcome assessment (e.g. closed head injury, liver contusion)
Elevated liver function tests (AST, ALT, alkaline phosphatase, or total bilirubin > 2 times the upper limit of normal) at screening
History of systemic lupus erythematosus (SLE)
Isolated radicular motor deficit
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

Princess Alexandra Hospital

Brisbane, AustraliaOpen Princess Alexandra Hospital in Google Maps
Recruiting

Foothills Medical Centre

Calgary, Canada
Recruiting

University of Alberta & Royal Alexandra Hospitals

Edmonton, Canada
Recruiting

London Health Sciences Centre - Victoria Hospital

London, Canada
Suspended7 Study Centers