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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by AOSpine North America Research Network
Sponsor:
Information provided by (Responsible Party):
AOSpine North America Research Network
ClinicalTrials.gov Identifier:
NCT01257828
First received: October 23, 2010
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Cervical Spondylotic Myelopathy
Drug: riluzole
Drug: Placebo medication
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Riluzole in Patients With Cervical Spondylotic Myelopathy Undergoing Surgical Treatment. A Randomized, Double-Blind, Placebo-controlled Multi-Center Study

Resource links provided by NLM:


Further study details as provided by AOSpine North America Research Network:

Primary Outcome Measures:
  • Modified Japanese Orthopedic Association Score (mJOA) [ Time Frame: Before the surgery, 180 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Nurick Score [ Time Frame: Pre-surgical, 180 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.


Estimated Enrollment: 270
Study Start Date: December 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo medication and decompressive cervical spine surgery
Drug: Placebo medication
50mg BID orally for 14 days prior to surgery and 28 days after the surgery
Experimental: Riluzole
Riluzole in dose 50mg BID for 14 days prior to surgery and 28 days after the decompressive spine surgery
Drug: riluzole
50mg BID orally for 14 days prior to surgery and 28 days after the surgery
Other Name: Rilutek

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257828

Locations
United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Nicholas Theodore, MD    602-406-6335    nicholas.theodore@bnaneuro.net   
Contact: Jill Danielson    602-406-6335    jill.danielson@dignityhealth.org   
Principal Investigator: Nicholas Theodore, MD         
United States, California
UC Davis Spine Center Completed
Sacramento, California, United States, 95816
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Praveen Mummaneni, MD    415-476-2876    MummaneniP@neurosurg.ucsf.edu   
Contact: Erika Caccia    415-353-2240    Erika.Caccia@ucsf.edu   
Principal Investigator: Praveen Mummaneni, MD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30329
Contact: S. Tim Yoon, MD    404-778-7000    tim.yoon@emoryhealthcare.org   
Contact: Kyle Webb, MS    404-778-6381    kyle.webb2@emory.edu   
Principal Investigator: S. Tim Yoon, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Vincent Traynelis, MD    312-942-6644    Vincent_Traynelis@rush.edu   
Contact: Erica Dahlmeier, MPH    (312) 942-7877    Erica_Dahlmeier@rush.edu   
Principal Investigator: Vincent Traynelis, MD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Paul Arnold, MD    913-558-7587    parnold@kumc.edu   
Contact: Linda Jianas    913-558-3252    ljianas@kumc.edu   
Principal Investigator: Paul Arnold, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ahmad Nassr, MD    507-284-2511    nassr.ahmad@mayo.edu   
Contact: Vickie Silvernail    507-538-3561    silvernail.vickie@mayo.edu   
Principal Investigator: Ahmad Nassr, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Daniel Riew, MD    314-747-2567    riewd@wudosis.wustl.edu   
Contact: Sherry Banez-Muth, RN    314-362-6989    muths@wusm.wustl.edu   
Principal Investigator: Daniel Riew, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: H. Francis Farhadi, MD       Francis.Farhadi@osumc.edu   
Contact: Kathy Jelinek    (614) 688-6853    Kathryn.Jelinek@osumc.edu   
Principal Investigator: H. Francis Farhadi, MD         
United States, Pennsylvania
Thomas Jefferson University and Rothman Institute Orthopaedics Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Alexander Vaccaro, MD    215-955-3458    alexvaccaro3@aol.com   
Contact: Karen Plotke    267-339-3612    karen.plotke@rothmaninstitute.com   
Principal Investigator: Alexander Vaccaro, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Darrel S. Brodke, MD    801-587-5450    darrel.brodke@hsc.utah.edu   
Contact: Ashley Woodbury    801-587-5430    ashley.woodbury@hsc.utah.edu   
Principal Investigator: Darrel Brodke, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Christopher Shaffrey, MD    434-243-9728    CIS8Z@hscmail.mcc.virginia.edu   
Contact: Jenny De Jong, RN, BSN    434-243-9986    JAD5YC@hscmail.mcc.virginia.edu   
Principal Investigator: Christopher Shaffrey, MD         
United States, Washington
Harborview Medical Center Active, not recruiting
Seattle, Washington, United States, 98104
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N-2T9
Contact: W. Bradley Jacobs, MD    (403) 944-3406    wbjacobs@ucalgary.ca   
Contact: Ish Bains    (403) 944-4334    ish.bains@albertahealthservices.ca   
Principal Investigator: W. Bradley Jacobs, MD         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Henry Ahn, MD    416 864-6005    AhnH@smh.ca   
Contact: Kayee Tung    (416) 864-6060 ext 2713    tungk@smh.ca   
Principal Investigator: Henry Ahn         
University of Toronto Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Michael Fehlings, MD    (416) 603-5627    Michael.Fehlings@uhn.on.ca   
Contact: Yuriy Petrenko, MD    (416) 603-5285    yuriy.petrenko@uhn.on.ca   
Principal Investigator: Michael Fehlings, MD         
Canada, Quebec
Montreal Neurological Institute Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Benoit Goulet, MD    (514) 398-5738    benoit.goulet@muhc.mcgill.ca   
Contact: Julie Pelletier    (514) 398-5738    pelletj@videotron.ca   
Principal Investigator: Benoit Goulet, MD         
Canada, Saskatchewan
University of Saskatchewan, Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Daryl Fourney, MD    (306) 966-8814    daryl.fourney@usask.ca   
Contact: Lucy Liu    (306) 966-6054    lucy.liu@usask.ca   
Principal Investigator: Daryl Fourney, MD         
Sponsors and Collaborators
AOSpine North America Research Network
Investigators
Principal Investigator: Michael Fehlings, MD University Health Network, Toronto
Study Director: Branko Kopjar, MD University of Washington
  More Information

Publications:
Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT01257828     History of Changes
Other Study ID Numbers: SPN-10-001
Study First Received: October 23, 2010
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Additional relevant MeSH terms:
Bone Marrow Diseases
Hematologic Diseases
Riluzole
Anticonvulsants
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014