Clinical trial NCT02512588: A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Official title: A Randomized, Placebo-Controlled, Double-blind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Hypersomnia
Narcolepsy Without Cataplexy
Lead sponsor: Balance Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy Epworth Sleepiness Scale
timeFrame: After 14 days per treatment
Secondary outcomes:
measure: Efficacy Maintenance of Wakefulness Test
timeFrame: After 14 days per treatment
Other outcomes:
measure: Pharmacokinetics (Cmax)
timeFrame: Selected Days 14, 35, and 56
measure: Pharmacokinetics (Tmax)
timeFrame: Selected Days 14, 35, and 56
measure: Pharmacokinetics (T½)
timeFrame: Selected Days 1, 14, 31, 35, 42, and 56
measure: Pharmacokinetics (AUC)
timeFrame: Selected Days 1, 14, 21, 35, 42, and 56
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Palo Alto
country: United States
facility: Stanford Medicine Sleep Center
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Boulder
country: United States
facility: REM Sleep Medicine, Colorado Sleep Institute
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine Emory Sleep Center
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Macon
country: United States
facility: SleepMed of Central
state: Georgia
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 Center for Sleep
state: Massachusetts
city: Maplewood
country: United States
facility: Neurological Associate
state: Minnesota
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research Management Assoc.
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Institute
state: Oklahoma
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Future Search Trials of Neurology
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: Balance Therapeutics, Inc.
name: Lyndon Lien, PhD
role: STUDY_DIRECTOR
References: