Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis

You may not qualify if:

• Subject in whom other causes of neuromuscular weakness have not been excluded.
• Subject with a diagnosis of another neurodegenerative disease (e.g. Parkinson's or Alzheimer's disease).
• Assisted ventilation or gastrostomy of any type during the preceding 3 months prior to screening or predicted to be required within the randomised, double-blind cross-over part of the study.
• Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia.
• Any major surgery within 1 month before the screening visit or patients who are scheduled for any major surgery during the planned study period.
• Potassium \< 3.7 mmol/l or \> 5.5 mmol/l at screening.
• Creatinine \> 170 μmol/l at screening or on dialysis.
• Blood haemoglobin \< 10 g/dl at screening.
• Clinically significant hepatic impairment at the discretion of the investigator.
• Women of reproductive age without a negative pregnancy test and without a commitment to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives and long acting progestin agents), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included.
• Known hypersensitivity to levosimendan.
• Administration of levosimendan within 30 days prior to screening visit.
• Patients with history of botulinum toxin treatment for any reason.
• Patients with known history of human immunodeficiency virus infection.
• History of significant arrhythmias or other cardiac events
• +4 more criteria