A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Hypersomnia, Narcolepsy Without Cataplexy

In brief

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).

Key facts

Study ID

NCT02512588

Run by

Balance Therapeutics

People needed

120

Starts

2015-09-01

Expected to finish

2018-02-01

Last updated by the study team

2019-01-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic treatment for the condition
• 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

You may not qualify if…

• Any disorder causing hypersomnia other than IH or Narcolepsy Type 2
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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