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Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect) (CSM-Protect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01257828
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
AOSpine North America Research Network

Tracking Information
First Submitted Date  ICMJE October 23, 2010
First Posted Date  ICMJE December 10, 2010
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
Modified Japanese Orthopedic Association Score (mJOA) [ Time Frame: Before the surgery, 180 days ]
The mJOA is a clinician administered scale. It evaluates four clinical dimensions; motor dysfunction score for upper and lower extremities, sensation loss and sphincter dysfunction. The total score ranges from 0 (worst) to 18 (best).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Nurick Score [ Time Frame: Pre-surgical, 180 days ]
    Nurick score is a simple measure of neurological dysfunction and ranges from 0 (best) to 6 (worst).
  • SF-36v2.0 [ Time Frame: Before the surgery, 180 days ]
    The SF36v2.0 is a health-related quality of life instrument that evaluates health status accross eight health dimensions.
  • Neck Disability Index (NDI) [ Time Frame: Before the surgery, 180 days ]
    The NDI evaluates patient self-reported functional outcomes related to neck conditions. The NDI score ranges from 0 (best) to 100 (worst).
  • Cervical Pain Numeric Rating Scale [ Time Frame: Before the surgery, 180 days ]
    Simple numeric rating scale with choises of answers from 0 (no pain) to 10 (worst imaginable pain)
  • EQ-5D [ Time Frame: Before the surgery, 180 days ]
    EQ-5D™ is a standardised instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status.
  • American Spinal Injury Association Score (ASIA) [ Time Frame: Before the surgery, 180 days ]
    The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
  • Nurick Score [ Time Frame: Pre-surgical, 180 days ]
    Nurick score is a simple measure of neurological dysfunction and ranges from 0 (best) to 6 (worst).
  • SF-36v2.0 [ Time Frame: Before the surgery, 180 days ]
    The SF36v2.0 is a health-related quality of life instrument that evaluates health status accross eight health dimensions.
  • Neck Disability Index (NDI) [ Time Frame: Before the surgery, 180 days ]
    The NDI evaluates patient self-reported functional outcomes related to neck conditions. The NDI score ranges from 0 (best) to 100 (worst).
  • Cervical Pain Numeric Rating Scale [ Time Frame: Before the surgery, 180 days ]
    Simple numeric rating scale with choises of answers from 0 (no pain) to 10 (worst imaginable pain)
  • EQ-5D [ Time Frame: Before the surgery, 180 days ]
    EQ-5D™ is a standardised instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status.
  • sia American Spinal Injury Association Score (ASIA) [ Time Frame: Before the surgery, 180 days ]
    The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)
Official Title  ICMJE Efficacy of Riluzole in Patients With Cervical Spondylotic Myelopathy Undergoing Surgical Treatment. A Randomized, Double-Blind, Placebo-controlled Multi-Center Study
Brief Summary CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury worldwide. While there is evidence from the recently completed SpineNet prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have remaining neurological impairment. While surgery is relatively safe, approximately 3% of patients maintain a neurological problem. Given this background and data from preclinical models of non-traumatic and traumatic spinal cord injury, there is strong evidence to consider the potential benefit of adding a neuroprotective drug which aids in the treatment of patients with CSM whom are undergoing surgical decompression. Riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this background, there is a strong basis to consider studying the potential neurological benefits of Riluzole as a treatment to surgical decompression in patients with CSM.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Spondylotic Myelopathy
Intervention  ICMJE
  • Drug: riluzole
    50mg BID orally for 14 days prior to surgery and 28 days after the surgery
    Other Name: Rilutek
  • Drug: Placebo medication
    50mg BID orally for 14 days prior to surgery and 28 days after the surgery
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo medication and decompressive cervical spine surgery
    Intervention: Drug: Placebo medication
  • Experimental: Riluzole
    Riluzole in dose 50mg BID for 14 days prior to surgery and 28 days after the decompressive spine surgery
    Intervention: Drug: riluzole
Publications * Fehlings MG, Wilson JR, Karadimas SK, Arnold PM, Kopjar B. Clinical evaluation of a neuroprotective drug in patients with cervical spondylotic myelopathy undergoing surgical treatment: design and rationale for the CSM-Protect trial. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S68-75. doi: 10.1097/BRS.0b013e3182a7e9b0. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2010)
270
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 80 years
  • Diagnosis of symptomatic cervical spondylotic myelopathy defined as a combination of:

    1. one or more of the following symptoms:

      • Numb hands
      • Clumsy hands
      • Impairment of gait
      • Bilateral arm paresthesiae
      • l'Hermitte's phenomena
      • Weakness And,
    2. one or more of the following signs:

      • Corticospinal distribution motor deficits
      • Atrophy of hand intrinsic muscles
      • Hyperreflexia
      • Positive Hoffman sign
      • Upgoing plantar responses
      • Lower limb spasticity
      • Broad based, unstable gait And,
    3. MRI evidence of cervical spondylotic myelopathy
  • Scheduled for an elective surgery for cervical spondylotic myelopathy
  • Preoperative mJOA score ≥8 and ≤14
  • Women of child bearing potential must be:

    • Postmenopausal defined as amenorrhea for at least 2 years.
    • Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
    • Abstinent (at the discretion of the investigator)
    • Having other congenital or medical condition that prevents subject from becoming pregnant
    • If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), or male partner with a vasectomy. A double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel may be used as a birth control method.
    • Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test or a negative urine pregnancy test at screening before the first dose of study drug is received.

Exclusion Criteria:

  • Previous surgery for CSM
  • Concomitant symptomatic lumbar stenosis
  • CSM symptoms due to cervical trauma (at the discretion of the investigator)
  • Hypersensitivity to riluzole or any of its components
  • Neutropenia measured as absolute neutrophil count (ANC) measured in cells per microliter of blood of < 1500 at screening visit
  • Creatinine level of > 1.2 milligrams (mg) per deciliter (dl) in males or > 1.1 milligrams per deciliter in females at screening visit Liver enzymes (ALT or AST) 3x higher than normal values at screening visit.
  • Liver enzymes (ALT or AST) 3x higher than normal values at screening visit.
  • Subject will be using any of the following medications which are classified as CYP1A2 inhibitors or inducers*during the course of the drug regimen:

Inhibitors:

  • Ciprofloxacin
  • Enoxacin
  • Fluvoxamine
  • Methoxsalen
  • Mexiletine
  • Oral contraceptives
  • Phenylpropanolamine
  • Thiabendazole
  • Zileuton

Inducers:

  • Montelukast
  • Phenytoin

    *Note: no washout period required; if these medications are discontinued, subjects are eligible to be enrolled in the trial.

  • Systemic infection such as AIDS, HIV, and active hepatitis
  • Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
  • Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
  • Breastfeeding at screening visit and plan to continue during the course of the study drug
  • Unlikely to comply with the follow-up evaluation schedule
  • Unlikely to comply with investigational drug regime
  • Participation in a clinical trial of another investigational drug or device within the past 30 days
  • Is a prisoner
  • Unable to converse, read or write English at elementary school level
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257828
Other Study ID Numbers  ICMJE SPN-10-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AOSpine North America Research Network
Study Sponsor  ICMJE AOSpine North America Research Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Fehlings, MD University Health Network, Toronto
Study Director: Branko Kopjar, MD University of Washington
PRS Account AOSpine North America Research Network
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP