Clinical study IH202 is a Phase 2 randomized, double blind, placebo controlled, multiple cross-over study in Idiopathic Hypersomnia (IH) patients. The objective of this study is to assess efficacy and safety/ tolerability of BTD-001 in these patients. This study involves standard safety assessments which include physical and neurological exams, blood tests, and adverse event monitoring. Efficacy will be evaluated through measures of sleepiness, fatigue, attention, activities of daily living and others.
Randomized, double blind, placebo-controlled, cross-over study
Adult IH subjects
Small molecule product administered orally
Each patient will receive two different doses of BTD-001 and placebo in two separate treatment periods each two weeks in duration
6-7 visits over 8-12 week period
If interested in participating, please visit hypersomniastudy.com to complete a preliminary questionnaire.