A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Primary Purpose
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BTD-001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Hypersomnia
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
Sites / Locations
- Sleep Disorders Center of Alabama
- Stanford Medicine Sleep Center
- Pacific Research Network
- Empire Clinical Research
- REM Sleep Medicine, Colorado Sleep Institute
- PAB Clinical Research
- Clinical Research Group of St. Petersburg
- Emory University School of Medicine Emory Sleep Center
- NeuroTrials Research Inc
- SleepMed of Central
- Kentucky Research Group,
- The Center for Sleep and Wake Disorders
- NeuroCare Center for Sleep
- Neurological Associate
- Clayton Sleep Institute
- Columbia University Medical Center
- Wake Research Associates
- Community Research Management Assoc.
- Lynn Institute
- SleepMed of South Carolina
- Future Search Trials of Neurology
- Houston Sleep Center
- Swedish Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BTD-001
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Efficacy Epworth Sleepiness Scale
Epworth Sleepiness Scale
Secondary Outcome Measures
Efficacy Maintenance of Wakefulness Test
Maintenance of Wakefulness Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02512588
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balance Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BTD-001
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BTD-001
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Efficacy Epworth Sleepiness Scale
Description
Epworth Sleepiness Scale
Time Frame
After 14 days per treatment
Secondary Outcome Measure Information:
Title
Efficacy Maintenance of Wakefulness Test
Description
Maintenance of Wakefulness Test
Time Frame
After 14 days per treatment
Other Pre-specified Outcome Measures:
Title
Pharmacokinetics (Cmax)
Description
Pharmacokinetic parameters after multiple doses.
-Maximum serum concentration (Cmax)
Time Frame
Selected Days 14, 35, and 56
Title
Pharmacokinetics (Tmax)
Description
Pharmacokinetic parameters after multiple doses.
-Time of maximum plasma concentration (Tmax)
Time Frame
Selected Days 14, 35, and 56
Title
Pharmacokinetics (T½)
Description
Pharmacokinetic parameters after multiple doses.
-Elimination half life (T½)
Time Frame
Selected Days 1, 14, 31, 35, 42, and 56
Title
Pharmacokinetics (AUC)
Description
Pharmacokinetic parameters after multiple doses.
-Area under the concentration time curve (AUC)
Time Frame
Selected Days 1, 14, 21, 35, 42, and 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Lien, PhD
Organizational Affiliation
Balance Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Stanford Medicine Sleep Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Empire Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
REM Sleep Medicine, Colorado Sleep Institute
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Research Group of St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Emory University School of Medicine Emory Sleep Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
SleepMed of Central
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Kentucky Research Group,
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
The Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
NeuroCare Center for Sleep
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Neurological Associate
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Community Research Management Assoc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Lynn Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Future Search Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Houston Sleep Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
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