Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Calgary | OTHER |
| Alberta Paraplegic foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline | 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 |
|
| Placebo | Placebo Comparator | 250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ASIA Motor Recovery | 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. | assessed at time points: day 1,3,7, week 3,6, month 3,6,12 |
| Measure | Description | Time Frame |
|---|---|---|
| ASIA sensory recovery | 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 | assessed at time points: day 1,3,7 week 3,6, months 3,6,12 |
| Measure | Description | Time Frame |
|---|---|---|
| effect of injury severity | 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 | as per primary and secondary outcomes |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Casha, MD PhD FRCSC | Contact | 1-403-944-3405 | scasha@ucalgary.ca | |
| John Hurlbert, MD PhD FRCSC FACS | Contact | 1-403-944-4496 | jhurlber@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Steve Casha, MD PhD FRCSC | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Recruiting | Brisbane | Queensland | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22505632 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Surgical spinal cord decompression | Procedure | 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) | Procedure | 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. |
|
| Spinal cord Independence measure (SCIM) |
Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points. |
| assessed at time points: week 6, month 3,6,12 |
| Short Form 36 (SF-36) | functional outcome as assessed by the short form 36 (SF-36) quality of Life assessment at specified time points. | assessed at time points: week 6, month 3,6,12 |
| ASIA impairment grade | change in ASIA impairment grade at specified time points | assessed at time points: day 1,3,7 week 3,6 month 3,6,12 |
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
|
| University of Alberta & Royal Alexandra Hospitals | Recruiting | Edmonton | Alberta | Canada |
|
| Queen Elizabeth II Health Sciences Centre | Not yet recruiting | Halifax | Nova Scotia | Canada |
|
| London Health Sciences Centre - Victoria Hospital | Recruiting | London | Ontario | Canada |
|
| The Ottawa Hospital - Civic Campus | Not yet recruiting | Ottawa | Ontario | Canada |
|
| Hôpital Du Sacré-Cœur de Montréal | Not yet recruiting | Montreal | Quebec | Canada |
| D014947 | Wounds and Injuries |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |