A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Hypersomnia

In brief

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

Key facts

Study ID

NCT03542851

Run by

Balance Therapeutics

People needed

80

Starts

2018-05-29

Expected to finish

2020-05-28

Last updated by the study team

2020-04-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.