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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 (

Brief 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).

Detailed Summary:
Sponsor: Balance Therapeutics

Current Primary Outcome: Efficacy Epworth Sleepiness Scale [ Time Frame: After 14 days per treatment ]

Epworth Sleepiness Scale


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy Maintenance of Wakefulness Test [ Time Frame: After 14 days per treatment ]

Maintenance of Wakefulness Test


Original Secondary Outcome: Same as current

Information By: Balance Therapeutics

Dates:
Date Received: July 23, 2015
Date Started: September 2015
Date Completion: January 2018
Last Updated: March 27, 2017
Last Verified: March 2017