Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Balance Therapeutics

Stanford Investigator(s):


  • Drug: BTD-001
  • Drug: Placebo


Phase 2


Inclusion Criteria:

   - 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:

   - 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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Emmanuel Mignot, MD