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Antibiotic

Minocycline for Spinal Cord Injury

Phase 3
Waitlist Available
Led By Steve Casha, MD PhD FRCSC
Research Sponsored by Rick Hansen Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at time points: week 6, month 3,6,12
Awards & highlights

Study 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.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at time points: week 6, month 3,6,12
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at time points: week 6, month 3,6,12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ASIA Motor Recovery
Secondary outcome measures
ASIA impairment grade
ASIA sensory recovery
Short Form 36 (SF-36)
+1 more
Other outcome measures
effect of injury severity

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MinocyclineExperimental Treatment3 Interventions
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: PlaceboPlacebo Group3 Interventions
250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minocycline
FDA approved

Find a Location

Who is running the clinical trial?

Rick Hansen InstituteLead Sponsor
9 Previous Clinical Trials
517 Total Patients Enrolled
University of CalgaryOTHER
792 Previous Clinical Trials
868,906 Total Patients Enrolled
Alberta Paraplegic foundationUNKNOWN

Frequently Asked Questions

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~21 spots leftby Apr 2025