REgeneration in CErvical DEgenerative myelopathy (RECEDE): a multi-centre, double-blind, randomised, placebo controlled trial assessing the efficacy of Ibudilast as an adjuvant treatment to decompressive surgery for degenerative cervical myelopathy
Degenerative cervical myelopathy
Participants in the trial will be randomly allocated to one of two groups by their unique trial ID number. One group will be given Ibudilast, the test drug, while the other group will receive a placebo that will appear the same as the Ibudilast. Neither participants nor their doctors will know which group they have been allocated to. By comparing the outcomes between the two groups, we will be able to see whether giving Ibudilast provides a benefit to patients. This study includes a placebo arm since it is not known whether Ibudilast provides benefit and hence a position of equipoise exists. Each participant will be on trial for approximately 15 months (±21 days). Ibudilast treatment will start within 10 weeks prior to surgery and will continue for up to 24 weeks after surgery. Treatment will be halted 5 days prior to surgery and resumed at the previous maximum dose right after operation. Patients will be taking Ibudilast for a maximum of 34 weeks. Participants will be followed up for 12 months after surgery. The majority of participants will be identified from participating neurosurgical centres, typically via outpatient clinics. After being told about the study and given the participant information sheet, potential participants will have time to think about participating, and they will have the opportunity to ask a member of the research team any questions they might have. If potential participants decide to take part, they will be asked to sign a consent form and will be given a copy of the participant information sheet and informed consent form to keep. Then they will be given a unique trial ID number that, along with their date of birth, will be used to identify them during their involvement in the trial. Screening procedures to establish eligibility include a review of participant medical history, age, DCM characteristics, and medications. Clinicians will also perform the following assessments: neurological examination, mJOA assessment, laboratory tests (
1. Aged 18 to 80 years 2. Informed consent to participate given 3. Degenerative cervical myelopathy 4. Preoperative mJOA score ≥8 and ≤14 5. Scheduled for first surgical decompression as part of usual clinical practice
1. Previous surgery for degenerative cervical myelopathy 2. Degenerative cervical myelopathy symptoms due to cervical trauma, determined at the discretion of the investigator 3. Hypersensitivity to Ibudilast or any of the formulation components 4. Evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation (including ALP >1.5x ULN; ALT or AST >2x ULN; GGT >3x ULN) 5. Evidence of thrombocytopenia at screening through laboratory evaluation including platelet count <5000 6. Active malignancy defined as a history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for ≥5 years 7. Recent history (≤3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or trial participation 8. Female patients with child bearing potential who are unwilling or unable to use reliable methods of contraception 9. Female patients who are pregnant, lactating or planning pregnancy during the course of the trial 10. Inability to comply with trial procedures or follow-up schedule including IMP regime 11. Unable to take gelatin-based product 12. Participation in another CTIMP or device trial ≤30 days before the time of recruitment 13. Functional disability from a concomitant neurological disease that would mask the symptoms of degenerative cervical myelopathy, determined at the discretion of the investigator. Including but not limited to stroke with a residual disability, cerebellar ataxia, Parkinson’s disease, symptomatic lumbar stenosis, and multiple sclerosis. 14. Resting pulse < 50 bpm, sinoatrial or atrioventricular block, uncontrolled hypertension, or corrected QT interval (QTcF) >450 ms 15. History of stomach or intestinal surgery or any other condition that could interfere with, or is judged by the investigator to interfere, with absorption, distribution, me