Clinical Trial Nuedexta in Subjects With ALS

Exclusion Criteria

• •Prior use of Nuedexta®
• •Current use of dextromethorphan, quinidine, quinine, mefloquine or opioids
• •History of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions
• •History of known sensitivity or intolerability to dextromethorphan
• •Use of an mono amine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI
• •Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure
• •Complete atrioventricular (AV) block without implanted pacemaker, or subjects at high risk of complete AV block
• •Concomitant use with drugs that both prolong QT interval and are metabolized by cytochrome P 2D6 (CYP2D6) (i.e., thioridazine or pimozide)
• •Exposure to any other experimental agent (off-label use or investigational) within 30 days prior to Baseline Visit
• •Invasive ventilator dependence, such as tracheostomy
• •Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia, according to PI judgment
• •Placement and/or usage of feeding tube
• •Pregnant women or women currently breastfeeding
• •Unable to turn diaphragm pacing device off during swallowing tests
• •Salivatory Botox within 90 days (3 months) of screening
• •Salivatory radiation within 180 days (6 months) of screening