A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

A Randomized, Placebo-Controlled, Double-blind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).

Inclusion Criteria:

• Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic treatment for the condition
• Usual nightly total sleep at least 6 hours as single major rest period without naps
• Epworth Sleepiness Scale of 10 or greater
• Males or females age 18 to 65 years

Exclusion Criteria:

• Any disorder causing hypersomnia other than IH or Narcolepsy Type 2
• Usual bedtime later than midnight
• Seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
• Beck Depression Inventory score greater than 19
• Beck Anxiety Inventory score greater than 15
• Significant history of or current suicidal ideation or behavior
• BMI less than 18 kg/m2 or greater than 39 kg/m2
• Positive toxicology screen or breathalyzer test
• Clinically significant abnormal findings on safety assessments
• Any significant medical or psychiatric disease or any condition that would put the patient at risk by participating in the study