Regeneration in Cervical Degenerative Myelopathy

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Nov 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a potential treatment for a condition called Degenerative Cervical Myelopathy (DCM), which is caused by wear and tear in the spine that compresses the spinal cord. This can lead to symptoms like numbness in the hands, balance problems, and in severe cases, paralysis. The main treatment for DCM is surgery, but many patients still experience significant disabilities afterward. The researchers want to see if a medication called Ibudilast, which is already used for other health issues, can help improve hand function, strength, balance, and reduce pain after surgery.

To be eligible for the trial, participants should be between 18 and 80 years old, have a confirmed diagnosis of DCM, and be scheduled for their first surgery. They will complete questionnaires and undergo assessments before and after surgery, including MRI scans to check the treatment's effectiveness. The trial is ongoing and aims to enroll patients at multiple sites in the UK. If you're considering participating, you'll be contributing to important research that could help improve outcomes for many individuals with DCM.

Gender

ALL

Eligibility 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