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A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (ARISE2)

Primary Purpose

Idiopathic Hypersomnia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pentetrazol (PTZ)
Placebo oral capsule
Sponsored by
Balance Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypersomnia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sleep Disorders Center of Alabama
  • Mayo Clinic Hospital
  • SDS Clinical Trials
  • Pacific Research Network
  • Sleep Medicine Specialists of California
  • Santa Monica Clinical Trials
  • REM Sleep Medicine
  • PAB Clinical Research
  • Sleep Medicine Specialists of South Florida
  • Florida Premier Research Institute
  • NeuroTrials Research Inc.
  • Sleep Practicioners
  • Northshore Sleep Medicine
  • Fort Wayne Neurology
  • Rowe Neurology Institute
  • Kentucky Research Group
  • The Center for Sleep and Wake Disorders
  • NeuroCare
  • Sleep and Attention Disorders Institute
  • Neuroscience Center
  • St. Luke's Sleep Medicine and Research Center
  • Columbia University - Department of Neurology
  • Albert Einstein College of Medicine
  • Research Carolina of Huntersville
  • Intrepid Research
  • Lynn Health Science Institute
  • Geisinger
  • Consolidated Clinical Trials
  • Bogan Sleep Consultants, LLC
  • Future Search Trials
  • Houston Sleep Center
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subject Receives BTD001 first

Subject Receives Placebo first

Arm Description

Outcomes

Primary Outcome Measures

The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Measurements: IH Symptom Diary.

Secondary Outcome Measures

The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Measurements: ESS (Epworth Sleepiness Scale).
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Measurements: MWT (Maintenance of Wakefulness Test)

Full Information

First Posted
May 1, 2018
Last Updated
April 28, 2020
Sponsor
Balance Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03542851
Brief Title
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Acronym
ARISE2
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balance Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypersomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subject Receives BTD001 first
Arm Type
Experimental
Arm Title
Subject Receives Placebo first
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pentetrazol (PTZ)
Other Intervention Name(s)
PTZ
Intervention Description
BTD-001 is an oral capsule of PTZ.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo will be presented as oral capsule.
Primary Outcome Measure Information:
Title
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Description
Measurements: IH Symptom Diary.
Time Frame
Change from baseline.
Secondary Outcome Measure Information:
Title
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Description
Measurements: ESS (Epworth Sleepiness Scale).
Time Frame
Change from baseline.
Title
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Description
Measurements: MWT (Maintenance of Wakefulness Test)
Time Frame
Change from baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morgan Lam
Organizational Affiliation
Chief Operating Officer
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
Mayo Clinic Hospital
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
SDS Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Sleep Medicine Specialists of California
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
REM Sleep Medicine
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
Sleep Medicine Specialists of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Florida Premier Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
NeuroTrials Research Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Sleep Practicioners
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Northshore Sleep Medicine
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Fort Wayne Neurology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
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
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Sleep and Attention Disorders Institute
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Neuroscience Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Facility Name
St. Luke's Sleep Medicine and Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Columbia University - Department of Neurology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Albert Einstein College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Carolina of Huntersville
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
95242
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Geisinger
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Consolidated Clinical Trials
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Future Search Trials
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

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

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