This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
BTD-001 is an oral capsule of PTZ.
Placebo will be presented as oral capsule.
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Measurements: IH Symptom Diary.
Time frame: Change from baseline.
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Measurements: ESS (Epworth Sleepiness Scale).
Time frame: Change from baseline.
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Measurements: MWT (Maintenance of Wakefulness Test)
Time frame: Change from baseline.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Mayo Clinic Hospital
Scottsdale, Arizona, United States
SDS Clinical Trials
Orange, California, United States
Pacific Research Network
San Diego, California, United States
Sleep Medicine Specialists of California
San Ramon, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
REM Sleep Medicine
Boulder, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
...and 22 more locations