Clinical Trial Information

IH201

Clinical study IH201 is a Phase 2 randomized, double blind, placebo controlled, multiple cross-over study in Idiopathic Hypersomnia (IH) and Narcolepsy Type 2 (Na-2) patients. The objective of this study is to assess efficacy, pharmacokinetics, 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.

Summary:

  • Randomized, double blind, placebo-controlled, cross-over study
  • Adult IH and Na-2 subjects
  • Small molecule product administered orally
  • Each patient will receive two different doses of BTD-001 and placebo in three separate treatment periods each two weeks in duration
  • Screening and 6 clinic visits over a 14 week period