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Cervical Spondylotic MyelopathyPhase 3CSM-ProtectNCT01257828

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

A Phase 3 study testing riluzole in people with Cervical Spondylotic Myelopathy, run by AOSpine North America Research Network at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cervical Spondylotic Myelopathy
What is being tested?
riluzole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
21 sitesin 2 countries
Study dates
Mar 2012to 1 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 80 years
  • Diagnosis of symptomatic cervical spondylotic myelopathy defined as a combination of:
  • one or more of the following symptoms:
  • Numb hands
  • Clumsy hands
  • Impairment of gait
Show all 27Show fewer
  • Bilateral arm paresthesiae
  • l'Hermitte's phenomena
  • Weakness And,
  • 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,
  • 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.

Who cannot join

  • 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.
Show all 31Show fewer
  • 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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States15 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30329

  • Louisiana State University

    Baton Rouge, Louisiana, 70803

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Ohio State University

    Columbus, Ohio, 43210

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Rothman Institute Orthopaedics

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC Davis Spine Center

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84108

  • University of California - San Francisco

    San Francisco, California, 94143

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Washington University Orthopaedics

    St Louis, Missouri, 63110

Other trials in United States

Canada6 sites

  • University of Calgary

    Calgary, Alberta, T2N-2T9

  • McGill University Health Centre

    Montral, Quebec, H3H 2L9

  • Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • University of Saskatchewan, Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • University of Toronto Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Efficacy of Riluzole in Patients With Cervical Spondylotic Myelopathy Undergoing Surgical Treatment. A Randomized, Double-Blind, Placebo-controlled Multi-Center Study

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.

Being tested
riluzole, Placebo medication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • riluzoleDrug

    Also called Rilutek

    50mg BID orally for 14 days prior to surgery and 28 days after the surgery

  • Placebo medicationDrug

    50mg BID orally for 14 days prior to surgery and 28 days after the surgery

Study groups in NCT01257828
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo medication and decompressive cervical spine surgery
Receives: Drug: Placebo medication
RiluzoleExperimentalRiluzole in dose 50mg BID for 14 days prior to surgery and 28 days after the decompressive spine surgery
Receives: Drug: riluzole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Japanese Orthopedic Association Score (mJOA)

    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).

    Measured: Before the surgery, 180 days

Secondary outcomes (6)

  1. Nurick Score

    Nurick score is a simple measure of neurological dysfunction and ranges from 0 (best) to 6 (worst).

    Measured: Pre-surgical, 180 days

  2. SF-36v2.0

    The SF36v2.0 is a health-related quality of life instrument that evaluates health status accross eight health dimensions.

    Measured: Before the surgery, 180 days

  3. Neck Disability Index (NDI)

    The NDI evaluates patient self-reported functional outcomes related to neck conditions. The NDI score ranges from 0 (best) to 100 (worst).

    Measured: Before the surgery, 180 days

  4. Cervical Pain Numeric Rating Scale

    Simple numeric rating scale with choises of answers from 0 (no pain) to 10 (worst imaginable pain)

    Measured: Before the surgery, 180 days

  5. EQ-5D

    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.

    Measured: Before the surgery, 180 days

  6. American Spinal Injury Association Score (ASIA)

    The ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.

    Measured: Before the surgery, 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2010 (estimated)
  2. Study startMar 2012
  3. Primary completion15 Dec 2017
  4. Study completion1 Jun 2018

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01257828
Sponsor's protocol ID
SPN-10-001
Acronym
CSM-Protect
Status last verified
Nov 2018
First submitted
23 Oct 2010
Last updated
2 Nov 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 23962993

  • Bak AB, Moghaddamjou A, Arnold PM, Harrop JS, Fehlings MG. Chronic pain after decompression for degenerative cervical myelopathy: a pooled trajectory analysis of individual participant data. Pain. 2026 Mar 1;167(3):654-662. doi: 10.1097/j.pain.0000000000003828. Epub 2025 Oct 15.

    PubMed 41086299

  • Wong R, Alvi MA, Quddusi AI, Fehlings MG. Role of Neck Pain in Defining Clinical Trajectories of Outcomes in Patients With Degenerative Cervical Myelopathy: Results of a Novel Machine Learning Algorithm. Global Spine J. 2026 Jan;16(1):218-229. doi: 10.1177/21925682251341263. Epub 2025 May 10.

    PubMed 40347099

  • Pedro KM, Alvi MA, Hejrati N, Moghaddamjou A, Fehlings MG. Elderly Patients Show Substantial Improvement in Health-Related Quality of Life After Surgery for Degenerative Cervical Myelopathy Despite Medical Frailty: An Ambispective Analysis of a Multicenter, International Data Set. Neurosurgery. 2024 Jun 1;94(6):1122-1131. doi: 10.1227/neu.0000000000002818. Epub 2024 Jan 10.

    PubMed 38197642

  • Fehlings MG, Badhiwala JH, Ahn H, Farhadi HF, Shaffrey CI, Nassr A, Mummaneni P, Arnold PM, Jacobs WB, Riew KD, Kelly M, Brodke DS, Vaccaro AR, Hilibrand AS, Wilson J, Harrop JS, Yoon ST, Kim KD, Fourney DR, Santaguida C, Massicotte EM, Kopjar B. Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. Lancet Neurol. 2021 Feb;20(2):98-106. doi: 10.1016/S1474-4422(20)30407-5. Epub 2020 Dec 22.

    PubMed 33357512

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing riluzole in people with Cervical Spondylotic Myelopathy, run by AOSpine North America Research Network at 21 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 27 inclusion and 31 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: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Japanese Orthopedic Association Score (mJOA) (time frame: Before the surgery, 180 days). 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 NCT01257828, which also lists 5 linked publications.

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 2 Nov 2018.

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