A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
NCT ID: NCT03542851
Last Updated: 2020-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2018-05-29
2020-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Subject Receives BTD001 first
Pentetrazol (PTZ)
BTD-001 is an oral capsule of PTZ.
Placebo oral capsule
Placebo will be presented as oral capsule.
Subject Receives Placebo first
Pentetrazol (PTZ)
BTD-001 is an oral capsule of PTZ.
Placebo oral capsule
Placebo will be presented as oral capsule.
Interventions
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Pentetrazol (PTZ)
BTD-001 is an oral capsule of PTZ.
Placebo oral capsule
Placebo will be presented as oral capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Balance Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Morgan Lam
Role: STUDY_DIRECTOR
Chief Operating Officer
Locations
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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
NeuroTrials Research Inc.
Atlanta, Georgia, United States
Sleep Practicioners
Macon, Georgia, United States
Northshore Sleep Medicine
Northbrook, Illinois, United States
Fort Wayne Neurology
Fort Wayne, Indiana, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Kentucky Research Group
Louisville, Kentucky, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
NeuroCare
Newton, Massachusetts, United States
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, United States
Neuroscience Center
Saint Paul, Minnesota, United States
St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri, United States
Columbia University - Department of Neurology
New York, New York, United States
Albert Einstein College of Medicine
New York, New York, United States
Research Carolina of Huntersville
Huntersville, North Carolina, United States
Intrepid Research
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Geisinger
Danville, Pennsylvania, United States
Consolidated Clinical Trials
Monroeville, Pennsylvania, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Future Search Trials
Austin, Texas, United States
Houston Sleep Center
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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BTD-001 IH202
Identifier Type: -
Identifier Source: org_study_id
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