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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Balance Therapeutics

Criteria

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