A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Exclusion Criteria

• •1. use of tracheostomy or mechanical ventilation within last 3 months
• •2. hepatic insufficiency or abnormal liver function
• •3. renal insufficiency
• •4. clinically significant psychiatric disorder
• •5. active malignancy
• •6. history of HIV, clinically significant chronic hepatitis, or other active infection
• •7. history of stomach or intestinal surgery or condition that could interfere with absorption, distribution, metabolism or secretion of study drug
• •8. history of alcohol or substance abuse within 3 months prior to entry (subjects will be instructed to refrain from alcohol during the study)
• •9. use of strong cytochrome P4503A inhibitors or inducers, anticonvulsants or other drugs known to interact strongly with perampanel.
• •10. pregnancy or lactation
• •11. clinically significant medical condition (other than ALS) that would pose a risk to the subject if they were to participate
• •12. know hypersensitivity to perampanel
• •13. currently participating, or has participated in a study with an investigation or marketed compound within 3 months of entry