Education and Training
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.
Intervention(s):
- drug: BTD-001
- drug: Placebo
Eligibility
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
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Emmanuel Mignot, MD
650-736-6607
Recruiting