A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
- Conditions
- Idiopathic Hypersomnia
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03542851
- Lead Sponsor
- Balance Therapeutics
- Brief Summary
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Males or Females age 18 to 70 years old
- Onset of hypersomnia between age 10 and 30 years of age
- An Epworth Sleepiness Scale score of greater than or equal to 11
- Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial)
- Females with a negative pregnancy test AND who are non-lactating
- Sexually active females of childbearing potential must be willing to use a highly effective method of birth control
- Sexually active males must have a vasectomy or use condoms
- History of any disorder causing hypersomnia other than IH
- Evidence of circadian-rhythm disorder
- Sleep apnea syndrome
- Use of CPAP
- Obese subjects with BMI greater than or equal to 35kg/m2
- History of or current seizure disorder or history of syncope, unexplained loss of consciousnesses or seizure in the past 3 years as well as any past history of benzodiazepine and/or barbiturate and/or alcohol-related withdrawal seizures
- Columbia-Suicide Severity Rating Scale (C-SSRS) findings consistent with significant history of or current suicidal ideation or behavior
- Subjects who fail to wash out medications for IH or any other prohibited medications
- Positive toxicology screen test during the Screening or Baseline Visits.
- Clinically significant abnormal findings from physical, electrocardiogram (ECG) or laboratory assessments at Screening
- History of or current significant pulmonary, cardiac, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carinomas or local cervical squamous cell carcinoma resolved after resection) or hypothyroidism (unless euthyroid at Screening Visit and treated with a stable dose of medication for at least 3 months prior to the Baseline Visit).
- Participation in a clinical drug trial within 4 weeks of Screening Visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Subject Receives Placebo first Pentetrazol (PTZ) - Subject Receives BTD001 first Pentetrazol (PTZ) - Subject Receives BTD001 first Placebo oral capsule - Subject Receives Placebo first Placebo oral capsule -
- Primary Outcome Measures
Name Time Method The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary Change from baseline. Measurements: IH Symptom Diary.
- Secondary Outcome Measures
Name Time Method The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures. Change from baseline. Measurements: ESS (Epworth Sleepiness Scale).
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures. Change from baseline. Measurements: MWT (Maintenance of Wakefulness Test)
Trial Locations
- Locations (32)
NeuroTrials Research Inc.
🇺🇸Atlanta, Georgia, United States
Florida Premier Research Institute
🇺🇸Winter Park, Florida, United States
Fort Wayne Neurology
🇺🇸Fort Wayne, Indiana, United States
Bogan Sleep Consultants, LLC
🇺🇸Columbia, South Carolina, United States
Mayo Clinic Hospital
🇺🇸Scottsdale, Arizona, United States
SDS Clinical Trials
🇺🇸Orange, California, United States
Sleep Medicine Specialists of California
🇺🇸San Ramon, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Santa Monica Clinical Trials
🇺🇸Santa Monica, California, United States
REM Sleep Medicine
🇺🇸Boulder, Colorado, United States
Sleep Practicioners
🇺🇸Macon, Georgia, United States
Northshore Sleep Medicine
🇺🇸Northbrook, Illinois, United States
Sleep and Attention Disorders Institute
🇺🇸Sterling Heights, Michigan, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
The Center for Sleep and Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Neuroscience Center
🇺🇸Saint Paul, Minnesota, United States
NeuroCare
🇺🇸Newton, Massachusetts, United States
Columbia University - Department of Neurology
🇺🇸New York, New York, United States
St. Luke's Sleep Medicine and Research Center
🇺🇸Chesterfield, Missouri, United States
Albert Einstein College of Medicine
🇺🇸New York, New York, United States
Research Carolina of Huntersville
🇺🇸Huntersville, North Carolina, United States
Geisinger
🇺🇸Danville, Pennsylvania, United States
Future Search Trials
🇺🇸Austin, Texas, United States
Consolidated Clinical Trials
🇺🇸Monroeville, Pennsylvania, United States
Rowe Neurology Institute
🇺🇸Lenexa, Kansas, United States
Sleep Medicine Specialists of South Florida
🇺🇸Miami, Florida, United States
Sleep Disorders Center of Alabama
🇺🇸Birmingham, Alabama, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Houston Sleep Center
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States