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

January 14, 2019 updated by: Balance Therapeutics

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Sleep Disorders Center of Alabama
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Medicine Sleep Center
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • Upland, California, United States, 91786
        • Empire Clinical Research
    • Colorado
      • Boulder, Colorado, United States, 80301
        • REM Sleep Medicine, Colorado Sleep Institute
    • Florida
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Saint Petersburg, Florida, United States, 33707
        • Clinical Research Group of St. Petersburg
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Neurotrials Research Inc
      • Atlanta, Georgia, United States, 30329
        • Emory University School of Medicine Emory Sleep Center
      • Macon, Georgia, United States, 31201
        • SleepMed of Central
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Kentucky Research Group,
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Center for Sleep and Wake Disorders
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • NeuroCare Center for Sleep
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Neurological Associate
    • Missouri
      • Saint Louis, Missouri, United States, 63143
        • Clayton Sleep Institute
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Community Research Management Assoc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Institute
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Sleepmed of South Carolina
    • Texas
      • Austin, Texas, United States, 78731
        • Future Search Trials of Neurology
      • Houston, Texas, United States, 77063
        • Houston Sleep Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Placebo
Drug: Placebo
Experimental: BTD-001
Drug: BTD-001

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy Epworth Sleepiness Scale
Time Frame: After 14 days per treatment
Epworth Sleepiness Scale
After 14 days per treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy Maintenance of Wakefulness Test
Time Frame: After 14 days per treatment
Maintenance of Wakefulness Test
After 14 days per treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (Cmax)
Time Frame: Selected Days 14, 35, and 56

Pharmacokinetic parameters after multiple doses.

-Maximum serum concentration (Cmax)
Selected Days 14, 35, and 56
Pharmacokinetics (Tmax)
Time Frame: Selected Days 14, 35, and 56

Pharmacokinetic parameters after multiple doses.

-Time of maximum plasma concentration (Tmax)
Selected Days 14, 35, and 56
Pharmacokinetics (T½)
Time Frame: Selected Days 1, 14, 31, 35, 42, and 56

Pharmacokinetic parameters after multiple doses.

-Elimination half life (T½)
Selected Days 1, 14, 31, 35, 42, and 56
Pharmacokinetics (AUC)
Time Frame: Selected Days 1, 14, 21, 35, 42, and 56

Pharmacokinetic parameters after multiple doses.

-Area under the concentration time curve (AUC)
Selected Days 1, 14, 21, 35, 42, and 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balance Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lyndon Lien, PhD, Balance Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTD-001 IH201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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