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

Trial ID or NCT#

NCT02512588

Status

recruiting iconRECRUITING

Purpose

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Contact us to find out if this trial is right for you.

Contact

Emmanuel Mignot, MD
650-736-6607

View on ClinicalTrials.gov