A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
ARISE2
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
1 other identifier
interventional
80
1 country
32
Brief Summary
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2018
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2018
CompletedStudy Start
First participant enrolled
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2020
CompletedApril 29, 2020
April 1, 2020
1.9 years
May 1, 2018
April 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Measurements: IH Symptom Diary.
Change from baseline.
Secondary Outcomes (2)
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Change from baseline.
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Change from baseline.
Study Arms (2)
Subject Receives BTD001 first
EXPERIMENTALSubject Receives Placebo first
EXPERIMENTALInterventions
BTD-001 is an oral capsule of PTZ.
Placebo will be presented as oral capsule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213, United States
Mayo Clinic Hospital
Scottsdale, Arizona, 85054, United States
SDS Clinical Trials
Orange, California, 92868, United States
Pacific Research Network
San Diego, California, 92128, United States
Sleep Medicine Specialists of California
San Ramon, California, 94583, United States
Santa Monica Clinical Trials
Santa Monica, California, 90404, United States
REM Sleep Medicine
Boulder, Colorado, 80301, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, 33126, United States
Florida Premier Research Institute
Winter Park, Florida, 32789, United States
NeuroTrials Research Inc.
Atlanta, Georgia, 30342, United States
Sleep Practicioners
Macon, Georgia, 31210, United States
Northshore Sleep Medicine
Northbrook, Illinois, 60062, United States
Fort Wayne Neurology
Fort Wayne, Indiana, 46804, United States
Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
Kentucky Research Group
Louisville, Kentucky, 40218, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815, United States
NeuroCare
Newton, Massachusetts, 02459, United States
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, 48314, United States
Neuroscience Center
Saint Paul, Minnesota, 55130, United States
St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri, 63017, United States
Columbia University - Department of Neurology
New York, New York, 10032, United States
Albert Einstein College of Medicine
New York, New York, 10467, United States
Research Carolina of Huntersville
Huntersville, North Carolina, 28078, United States
Intrepid Research
Cincinnati, Ohio, 95242, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Geisinger
Danville, Pennsylvania, 17822, United States
Consolidated Clinical Trials
Monroeville, Pennsylvania, 15146, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201, United States
Future Search Trials
Austin, Texas, 78731, United States
Houston Sleep Center
Houston, Texas, 77063, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Morgan Lam
Chief Operating Officer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2018
First Posted
May 31, 2018
Study Start
May 29, 2018
Primary Completion
May 1, 2020
Study Completion
May 28, 2020
Last Updated
April 29, 2020
Record last verified: 2020-04