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Minocycline in Acute Spinal Cord Injury (MASC)

Primary Purpose

Spinal Cord Injuries

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Minocycline

Placebo

Surgical spinal cord decompression

Maintenance of minimum mean arterial pressure (MAP)

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring minocycline, randomized control trial, phase 3, spinal cord injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Princess Alexandra HospitalRecruiting
Foothills Medical CentreRecruiting
University of Alberta & Royal Alexandra HospitalsRecruiting
Queen Elizabeth II Health Sciences Centre
London Health Sciences Centre - Victoria HospitalRecruiting
The Ottawa Hospital - Civic Campus
Hôpital Du Sacré-Cœur de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minocycline

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Spinal cord Independence measure (SCIM)

Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points.

Short Form 36 (SF-36)

functional outcome as assessed by the short form 36 (SF-36) quality of Life assessment at specified time points.

ASIA impairment grade

change in ASIA impairment grade at specified time points

Full Information

NCT ID

NCT01828203

First Posted

April 5, 2013

Last Updated

October 29, 2014

Sponsor

Rick Hansen Institute

Collaborators

University of Calgary, Alberta Paraplegic foundation

1. Study Identification

Unique Protocol Identification Number

NCT01828203

Brief Title

Minocycline in Acute Spinal Cord Injury (MASC)

Official Title

Phase III Study of Minocycline in Acute Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rick Hansen Institute

Collaborators

University of Calgary, Alberta Paraplegic foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Minocycline

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Minocycline

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Procedure

Intervention Name(s)

Surgical spinal cord decompression

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Maintenance of minimum mean arterial pressure (MAP)

Intervention Description

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 Information:

Title

ASIA Motor Recovery

Description

Time Frame

assessed at time points: day 1,3,7, week 3,6, month 3,6,12

Secondary Outcome Measure Information:

Title

ASIA sensory recovery

Description

Time Frame

assessed at time points: day 1,3,7 week 3,6, months 3,6,12

Title

Spinal cord Independence measure (SCIM)

Description

Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points.

Time Frame

assessed at time points: week 6, month 3,6,12

Title

Short Form 36 (SF-36)

Description

functional outcome as assessed by the short form 36 (SF-36) quality of Life assessment at specified time points.

Time Frame

assessed at time points: week 6, month 3,6,12

Title

ASIA impairment grade

Description

change in ASIA impairment grade at specified time points

Time Frame

assessed at time points: day 1,3,7 week 3,6 month 3,6,12

Other Pre-specified Outcome Measures:

Title

effect of injury severity

Description

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

Time Frame

as per primary and secondary outcomes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steve Casha, MD PhD FRCSC

Phone

1-403-944-3405

scasha@ucalgary.ca

First Name & Middle Initial & Last Name or Official Title & Degree

John Hurlbert, MD PhD FRCSC FACS

Phone

1-403-944-4496

jhurlber@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Casha, MD PhD FRCSC

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Alexandra Hospital

City

Brisbane

State/Province

Queensland

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Schuetz, MD

Facility Name

Foothills Medical Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steve Casha, MD PhD FRCSC

Phone

1-403-944-3405

scasha@ucalgary.ca

First Name & Middle Initial & Last Name & Degree

John Hurlbert, MD PhD FRCSC FACS

Phone

1-403-944-4496

jhurlber@ucalgary.ca

First Name & Middle Initial & Last Name & Degree

Steve Casha, MD PhD FRCSC

First Name & Middle Initial & Last Name & Degree

John Hurlbert, MD PhD FRCSC FACS

First Name & Middle Initial & Last Name & Degree

Bradley Jacobs, MD FRCSC

Facility Name

University of Alberta & Royal Alexandra Hospitals

City

Edmonton

State/Province

Alberta

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Nataraj, MD

Facility Name

Queen Elizabeth II Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sean Christie, MD

Facility Name

London Health Sciences Centre - Victoria Hospital

City

London

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chris Bailey, MD

Facility Name

The Ottawa Hospital - Civic Campus

City

Ottawa

State/Province

Ontario

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eve Tsai, MD

Facility Name

Hôpital Du Sacré-Cœur de Montréal

City

Montreal

State/Province

Quebec

Country

Canada

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

22505632

Citation

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.

Results Reference

background

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Minocycline in Acute Spinal Cord Injury (MASC)

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