Spinal Cord InjuriesPhase 3NCT01828203
Minocycline in Acute Spinal Cord Injury (MASC)
A Phase 3 study testing Minocycline, Surgical spinal cord decompression and Maintenance of minimum mean arterial pressure (MAP) in people with Spinal Cord Injuries, run by Rick Hansen Institute at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Minocycline, Surgical spinal cord decompression and Maintenance of minimum mean arterial pressure (MAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2013to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites, 6 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Steve Casha, MD PhD FRCSC, 1-403-944-3405, scasha@ucalgary.ca
John Hurlbert, MD PhD FRCSC FACS, 1-403-944-4496, jhurlber@ucalgary.ca
- Recruiting
University of Alberta & Royal Alexandra Hospitals
Edmonton, Alberta
Andrew Nataraj, MD
- Not yet recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Sean Christie, MD
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario
Chris Bailey, MD
- Not yet recruiting
Hôpital Du Sacré-Cœur de Montréal
Montreal, Quebec
- Not yet recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario
Eve Tsai, MD
Australia1 site, 1 recruiting
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland
Michael Schuetz, MD
About this study
Official title: Phase III Study of Minocycline in Acute Spinal Cord Injury
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Minocycline, Placebo, Surgical spinal cord decompression, Maintenance of minimum mean arterial pressure (MAP)
- Keywords
- minocycline, randomized control trial, phase 3, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
PlaceboDrug
Surgical spinal cord decompressionProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Minocycline; Procedure: Surgical spinal cord decompression; Procedure: Maintenance of minimum mean arterial pressure (MAP) |
| Placebo | Placebo comparator | 250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days Receives: Drug: Placebo; Procedure: Surgical spinal cord decompression; Procedure: Maintenance of minimum mean arterial pressure (MAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed at time points: day 1,3,7, week 3,6, month 3,6,12
Secondary outcomes (4)
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
Measured: assessed at time points: day 1,3,7 week 3,6, months 3,6,12
Spinal cord Independence measure (SCIM)
Functional outcome as assessed by the Spinal cord independence Measure assessment at specified time points.
Measured: 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.
Measured: assessed at time points: week 6, month 3,6,12
ASIA impairment grade
change in ASIA impairment grade at specified time points
Measured: assessed at time points: day 1,3,7 week 3,6 month 3,6,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rick Hansen Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Alberta Paraplegic foundation
- Responsible party
- Principal investigator, Steve Casha, University of Calgary
- Investigators
- Steve Casha, MD PhD FRCSC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828203
- Sponsor's protocol ID
- RHI-1005
- Status last verified
- Oct 2014
- First submitted
- 5 Apr 2013
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22505632
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Minocycline in Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01828203
- Acronym / sponsor ID
- RHI-1005
- Conditions
- Spinal Cord Injuries
- Keywords
- minocycline, randomized control trial, phase 3, spinal cord injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Rick Hansen InstituteUniversity, hospital or other
- Collaborators
- University of Calgary, Alberta Paraplegic foundation
- Study start
- Jun 2013
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline, Procedure: Surgical spinal cord decompression, Procedure: Maintenance of minimum mean arterial pressure (MAP)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 | Drug: Placebo, Procedure: Surgical spinal cord decompression, Procedure: Maintenance of minimum mean arterial pressure (MAP)250 ml normal saline and infused over 30 minutes through central venous access twice daily for 7 days |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- History of systemic lupus erythematosus (SLE)
- Pre-existing hepatic or renal disease
- Tetracycline hypersensitivity
- Pregnancy or breast feeding
- Isolated radicular motor deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline | Drug | Minocycline |
| Placebo | Drug | Placebo |
| Surgical spinal cord decompressionSurgical 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. | Procedure or surgery | Minocycline, Placebo |
| Maintenance of minimum mean arterial pressure (MAP)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. | Procedure or surgery | Minocycline, Placebo |
Primary outcome
ASIA Motor Recovery
Time frame: assessed at time points: day 1,3,7, week 3,6, month 3,6,12
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.
4 secondary outcomes
ASIA sensory recovery
Time frame: assessed at time points: day 1,3,7 week 3,6, months 3,6,12
Spinal cord Independence measure (SCIM)
Time frame: assessed at time points: week 6, month 3,6,12
Short Form 36 (SF-36)
Time frame: assessed at time points: week 6, month 3,6,12
ASIA impairment grade
Time frame: assessed at time points: day 1,3,7 week 3,6 month 3,6,12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Background: PubMed 22505632Casha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Casha, MD PhD FRCSC principal investigator
University of Calgary
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline, Surgical spinal cord decompression and Maintenance of minimum mean arterial pressure (MAP) in people with Spinal Cord Injuries, run by Rick Hansen Institute at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Casha, MD PhD FRCSC (1-403-944-3405, scasha@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASIA Motor Recovery (time frame: assessed at time points: day 1,3,7, week 3,6, month 3,6,12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.