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

Balance Therapeutics

Status and phase

Completed

Phase 2

Conditions

Narcolepsy Without Cataplexy

Idiopathic Hypersomnia

Treatments

Drug: Placebo

Drug: BTD-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT02512588

BTD-001 IH201

Details and patient eligibility

About

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).

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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