Actively Recruiting
Regeneration in Cervical Degenerative Myelopathy
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2022-01-13
400
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Regeneration in Cervical Degenerative Myelopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with degenerative cervical myelopathy who have given informed consent
- Preoperative modified Japanese Orthopaedic Association (mJOA) score between 8 and 14
- Scheduled for first surgical decompression as part of usual NHS care
You will not qualify if you...
- Previous surgery for degenerative cervical myelopathy
- DCM symptoms caused by cervical trauma
- Allergy or hypersensitivity to Ibudilast or its components
- Acute or significant chronic hepatitis or impaired liver function
- Active invasive cancer or history of cancer with less than five years remission
- Recent history (less than 3 years) of substance dependency or major psychosocial issues
- Female patients of childbearing potential unwilling or unable to use reliable contraception
- Pregnant, lactating, or planning pregnancy during the trial
- Unable to comply with study procedures or medication schedule
- Unable to take gelatin-based products
- Participation in another drug or device trial within 30 days prior to recruitment
- Functional disability from neurological diseases that could mask DCM symptoms
- Resting heart rate below 50 bpm, heart block, uncontrolled high blood pressure, or prolonged QT interval
- History of stomach or intestinal surgery or conditions affecting drug absorption
- Inability to read, write, or understand English at primary school level
AI-Screening
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Trial Site Locations
Total: 1 location
1
Addenbrooke's Hospital
Cambridge, United Kingdom, CB20QQ
Actively Recruiting
Research Team
M
Mark R Kotter, PhD
CONTACT
P
Paula Kareclas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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