Table 2.
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 alkaline phosphatase (ALP) > 1.5 × upper limit of normal (ULN); alanine transaminas (ALT) or aspartate transaminase (AST) > 2 × ULN; gamma-glutamyl transferase (GGT) > 3 × ULN) |
5 | Evidence of thrombocytopaenia 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 childbearing 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 investigational medicinal product (IMP) regime |
11 | Unable to take gelatin-based product |
12 | Participation in another clinical trial of an investigational medicinal product (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 |
IMP, investigational medicinal product.