Treatment for Degenerative Cervical Myelopathy
Regeneration in Cervical Degenerative Myelopathy - 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
This study is testing if adding a medication called Ibudilast to surgery can help people with degenerative cervical myelopathy recover better and feel less pain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT04631471 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Ibudilast, a phosphodiesterase 4 inhibitor, in combination with cervical decompressive surgery for patients suffering from degenerative cervical myelopathy (DCM). DCM is a common spinal cord disorder that leads to significant disability and is often misdiagnosed as age-related decline. The trial aims to improve neurological recovery and quality of life for patients post-surgery, addressing the unmet clinical need for better outcomes. Participants will be monitored for improvements in motor function and pain relief following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for their first surgical decompression for degenerative cervical myelopathy with specific preoperative mJOA scores.
Not a fit: Patients with previous surgeries for DCM or those with certain medical conditions, such as active malignancy or hypersensitivity to Ibudilast, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance recovery and quality of life for patients suffering from degenerative cervical myelopathy.
How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in the use of Ibudilast for neurological recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suffering from degenerative cervical myelopathy as per established criteria who have granted informed consent to participate in the trial * Have a preoperative mJOA score ≥8 and ≤14 * Scheduled for first surgical decompression as part of usual NHS clinical practice Exclusion Criteria: * Previous surgery for DCM * DCM symptoms due to cervical trauma (at the discretion of the investigator) * Hypersensitivity to Ibudilast or any of the formulation components * 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 * 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 * Female patients with child bearing potential who are unwilling or unable to use reliable methods of contraception * Female patients who are pregnant, lactating or planning pregnancy during the course of the trial * Inability to comply with study procedures, IMP regime or follow-up schedule * Unable to take a gelatin based product * Participation in another CTIMP or device within the past 30 days from the time of recruitment * Functional disability from a commitment neurological disease that would mask the symptoms of DCM (at the discretion of the investigator). Including but not limited to stroke with residual disability, cerebellar ataxia, Parkinson's disease, symptomatic lumbar stenosis and multiple sclerosis * Resting pulse \< 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF \> 450 ms * 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, metabolism, or excretion of study drug * Unable to converse, read or write English at primary school level
Where this trial is running
Cambridge
- Addenbrooke's Hospital — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Benjamin Davies, MD — Cambridge University Hospital, Department of Neurosurgery
- Study coordinator: Mark R Kotter, PhD
- Email: mrk25@cam.ac.uk
- Phone: +44 1223 747476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.