Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 11-002973
NCT ID: NCT01257828
Sponsor Protocol Number: SPN-10-001
About this 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- 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
- 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
- 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.
- 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:
- Oral contraceptives
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.