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. 2023 Mar 7;13(3):e061294. doi: 10.1136/bmjopen-2022-061294

Table 2.

Exclusion criteria

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.