A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
NCT ID: NCT02512588
Last Updated: 2019-01-16
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2015-09-30
2018-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
NCT03542851
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
NCT04091438
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
NCT01124851
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
NCT03772314
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
NCT03748979
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BTD-001
BTD-001
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BTD-001
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Balance Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lyndon Lien, PhD
Role: STUDY_DIRECTOR
Balance Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford Medicine Sleep Center
Palo Alto, California, United States
Pacific Research Network
San Diego, California, United States
Empire Clinical Research
Upland, California, United States
REM Sleep Medicine, Colorado Sleep Institute
Boulder, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States
Emory University School of Medicine Emory Sleep Center
Atlanta, Georgia, United States
NeuroTrials Research Inc
Atlanta, Georgia, United States
SleepMed of Central
Macon, Georgia, United States
Kentucky Research Group,
Louisville, Kentucky, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
NeuroCare Center for Sleep
Newton, Massachusetts, United States
Neurological Associate
Maplewood, Minnesota, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Community Research Management Assoc.
Cincinnati, Ohio, United States
Lynn Institute
Oklahoma City, Oklahoma, United States
SleepMed of South Carolina
Columbia, South Carolina, United States
Future Search Trials of Neurology
Austin, Texas, United States
Houston Sleep Center
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BTD-001 IH201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.