Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis

Exclusion Criteria

• •Previous participation in another clinical study within the preceding 12 weeks
• •Proven SOD1- or FUS - mutation
• •Tracheostomy or assisted ventilation of any type during the preceding three months
• •Pregnancy or breast-feeding females
• •Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
• •Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
• •Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
• •Alcoholism
• •Cardiovascular disorder/arrhythmia
• •Impaired kidney function, defined as creatinine levels of 2.5 x upper limit of normal (ULN)
• •Impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of 3 x ULN
• •Liable to be not cooperative or comply with trial requirements as assessed by the investigator, or unable to be reached in the case of emergency