Assessing the efficacy of Ibudilast as an adjuvant treatment to decompressive surgery for degenerative cervical myelopathy
- Conditions
- Degenerative cervical myelopathyNervous System Diseases
- Registration Number
- ISRCTN16682024
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36882259/ protocol (added 08/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 362
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, metabolism, or excretion of IMP
16. Unable to converse, read, or write English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Motor dysfunction in upper and lower extremities, loss of sensation, and sphincter dysfunction measured by change in the modified Japanese Orthopaedic Association Score (mJOA), an18-point clinician-administered scale, between screening and 6 months post-operatively<br>2. Neck pain measured bychange in Visual Analogue Scale (VAS) neck pain between screening and 6 months post-operatively
- Secondary Outcome Measures
Name Time Method Health-related quality of life measured using the Physical Component Summary (PCS) and the Mental Component Summary (MCS) from the Short Form 36 (SF-36) v2 questionnaire between screening and 6 months post-operatively