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

Phase 2

Completed

• Conditions: Idiopathic Hypersomnia; Narcolepsy Without Cataplexy
• Interventions: Drug: Placebo; Drug: BTD-001

• Registration Number: NCT02512588
• Lead Sponsor: Balance Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-31
• Study Start: 2015-09
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BTD-001	BTD-001	-

Primary Outcome Measures

Name	Time	Method
Efficacy Epworth Sleepiness Scale	After 14 days per treatment	Epworth Sleepiness Scale

Secondary Outcome Measures

Name	Time	Method
Efficacy Maintenance of Wakefulness Test	After 14 days per treatment	Maintenance of Wakefulness Test

Trial Locations

Locations (23)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Emory University School of Medicine Emory Sleep Center; 🇺🇸 Atlanta, Georgia, United States

NeuroTrials Research Inc; 🇺🇸 Atlanta, Georgia, United States

Community Research Management Assoc.; 🇺🇸 Cincinnati, Ohio, United States

Lynn Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Houston Sleep Center; 🇺🇸 Houston, Texas, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

PAB Clinical Research; 🇺🇸 Brandon, Florida, United States

Clinical Research Group of St. Petersburg; 🇺🇸 Saint Petersburg, Florida, United States

SleepMed of Central; 🇺🇸 Macon, Georgia, United States

The Center for Sleep and Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

NeuroCare Center for Sleep; 🇺🇸 Newton, Massachusetts, United States

Stanford Medicine Sleep Center; 🇺🇸 Palo Alto, California, United States

Clayton Sleep Institute; 🇺🇸 Saint Louis, Missouri, United States

Empire Clinical Research; 🇺🇸 Upland, California, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Neurological Associate; 🇺🇸 Maplewood, Minnesota, United States

REM Sleep Medicine, Colorado Sleep Institute; 🇺🇸 Boulder, Colorado, United States

SleepMed of South Carolina; 🇺🇸 Columbia, South Carolina, United States

Future Search Trials of Neurology; 🇺🇸 Austin, Texas, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States

Kentucky Research Group,; 🇺🇸 Louisville, Kentucky, United States