Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS

Exclusion Criteria

• •Presence of clinically significant or unstable condition that would result in an increased risk of study participation or difficulty in interpretation of the study results.
• •Tremor or other movement disorder that would interfere with recording.
• •Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers.
• •Presence of laryngospasm or significant swallowing problems.
• •Inability to tolerate a spicy sensation in the mouth or stomach.
• •Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol.
• •Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening.
• •Pregnant, breastfeeding, or planning to become pregnant.
• •Blood pressure of ≥160 mmHg systolic and/or ≥100 mmHg diastolic.
• •Clinically significant abnormalities in laboratory findings (including screening complete electrolyte panel, complete blood count, liver function tests).