ISRCTN16682024进行中（未招募）3 期
REgeneration in CErvical DEgenerative myelopathy (RECEDE): 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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 362
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36882259/ protocol (added 08/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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