Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH

Inclusion criteria

• . At least 18 years of age at the time of consent
• . Body Mass Index (BMI) ≤35 kg/m2
• . Documented primary diagnosis of IH according to the International Classification of Sleep Disorders (ICSD-3) criteria
• . At the Screening Visit and Baseline Visit (start of OLTP), Epworth Sleepiness Scale (ESS) scores ≥11
• . Average nightly Total Sleep Time (TST) of ≥7 hours, per subject history and confirmed during screening.
• . Subject must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis) at Screening.
• . If currently treated with nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose during the study.
• . Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.

Exclusion criteria