NCT03542851

A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Balance Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

Detailed description

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia (IH). The objectives of this study are two-fold: 1) To evaluate the efficacy of BTD-001 in subjects with IH as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) To characterize the safety and tolerability of oral BTD-001 administered to subjects with IH.

Conditions

• Idiopathic Hypersomnia

Interventions

Type	Name	Description
DRUG	Pentetrazol (PTZ)	BTD-001 is an oral capsule of PTZ.
DRUG	Placebo oral capsule	Placebo will be presented as oral capsule.

Timeline

• Start date: 2018-05-29
• Primary completion: 2020-05-01
• Completion: 2020-05-28
• First posted: 2018-05-31
• Last updated: 2020-04-29

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study