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

Inclusion Criteria:

- Documented diagnosis of ALS diagnosis of less than 5 years.

- Greater than 6 fasciculations per minute noted at least in the tongue by clinical,
ultrasound, or EMG evaluation.

- Normal oral cavity exam at screening.

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).