Regeneration in Cervical Degenerative Myelopathy

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Myelopathy, Spinal Cord Diseases

In brief

Degenerative (wear and tear arthritis of the spine) Cervical (concerning the neck) Myelopathy (injury to the spinal cord), DCM, is the most common spinal cord disorder of adulthood. In DCM, arthritis of the spine causes compression of the spinal cord. The symptoms of DCM are often mistaken for natural consequences of ageing, including numb and clumsy hands, loss of coordination, imbalance, bladder and bowel problems. The weakness can progress to severe paralysis. Every year approximately 4 individuals in 100,000 undergo surgery for DCM; however, many more individuals are thought to suffer from DCM. The main treatment for DCM is surgery. The aim of surgery is to create space and remove the compression of the spinal cord. This is known to prevent further injury. Unfortunately, the post-operative improvements are often incomplete and many patients remain severely disabled. Improving outcome after surgery represents an important unmet clinical need. Clinical and preclinical findings indicate that the drug Ibudilast can stimulate neuroprotective and regenerative processes in the spinal cord. Ibudilast is well-tolerated and used to treat asthma and post-stroke dizziness in Japan and is currently being investigated for use in treating other neurological diseases. This study will investigate whether daily oral administration of Ibudilast for a maximum of 34 weeks can improve hand function, strength, balance, urinary problems and reduce pain. The study will initially be conducted at three sites in the UK, with more sites added as necessary. Individuals between 18-80 years old, diagnosed with DCM and scheduled for an operation for the first time will be invited to participate in the trial. The study will entail patient questionnaires and clinical assessments before surgery, shortly after surgery and 3, 6, and 12 months after surgery. Moreover, patients will undergo MRI scans pre-operatively and at 6-months postoperatively to determine whether the treatment was successful.

Key facts

Study ID: NCT04631471
Run by: Cambridge University Hospitals NHS Foundation Trust
People needed: 400
Starts: 2021-12-22
Expected to finish: 2026-09-01
Last updated by the study team: 2022-01-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Addenbrooke's Hospital — Cambridge, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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