Clinical trial NCT03542851: A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Official title: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Idiopathic Hypersomnia
Lead sponsor: Balance Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia (IH). The objectives of this study are two-fold: 1) To evaluate the efficacy of BTD-001 in subjects with IH as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) To characterize the safety and tolerability of oral BTD-001 administered to subjects with IH.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
timeFrame: Change from baseline.
Secondary outcomes:
measure: The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
timeFrame: Change from baseline.
measure: The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
timeFrame: Change from baseline.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Orange
country: United States
facility: SDS Clinical Trials
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Ramon
country: United States
facility: Sleep Medicine Specialists of California
state: California
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Boulder
country: United States
facility: REM Sleep Medicine
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc.
state: Georgia
city: Macon
country: United States
facility: Sleep Practicioners
state: Georgia
city: Northbrook
country: United States
facility: Northshore Sleep Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurology
state: Indiana
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: The Center for Sleep and Wake Disorders
state: Maryland
city: Newton
country: United States
facility: NeuroCare
state: Massachusetts
city: Sterling Heights
country: United States
facility: Sleep and Attention Disorders Institute
state: Michigan
city: Saint Paul
country: United States
facility: Neuroscience Center
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Sleep Medicine and Research Center
state: Missouri
city: New York
country: United States
facility: Columbia University - Department of Neurology
state: New York
city: New York
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Huntersville
country: United States
facility: Research Carolina of Huntersville
state: North Carolina
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Monroeville
country: United States
facility: Consolidated Clinical Trials
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Chief Operating Officer
name: Morgan Lam
role: STUDY_DIRECTOR
References: