Idiopathic HypersomniaPhase 2NCT02512588
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
A Phase 2 study testing BTD-001 in people with Idiopathic Hypersomnia and Narcolepsy Without Cataplexy, run by Balance Therapeutics at 23 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
- What is being tested?
- BTD-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 2015to Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University School of Medicine Emory Sleep Center
Atlanta, Georgia, 30329
NeuroTrials Research Inc
Atlanta, Georgia, 30342
Future Search Trials of Neurology
Austin, Texas, 78731
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
REM Sleep Medicine, Colorado Sleep Institute
Boulder, Colorado, 80301
PAB Clinical Research
Brandon, Florida, 33511
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Community Research Management Assoc.
Cincinnati, Ohio, 45255
SleepMed of South Carolina
Columbia, South Carolina, 29201
Houston Sleep Center
Houston, Texas, 77063
Kentucky Research Group,
Louisville, Kentucky, 40218
SleepMed of Central
Macon, Georgia, 31201
Neurological Associate
Maplewood, Minnesota, 55109
Columbia University Medical Center
New York, New York, 10032
NeuroCare Center for Sleep
Newton, Massachusetts, 02459
Lynn Institute
Oklahoma City, Oklahoma, 73112
Stanford Medicine Sleep Center
Palo Alto, California, 94304
Wake Research Associates
Raleigh, North Carolina, 27612
Pacific Research Network
San Diego, California, 92103
Swedish Medical Center
Seattle, Washington, 98122
Clayton Sleep Institute
St Louis, Missouri, 63143
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707
Empire Clinical Research
Upland, California, 91786
About this study
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
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).
- Being tested
- BTD-001, Placebo
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTD-001Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BTD-001 | Experimental | Not described Receives: Drug: BTD-001 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Epworth Sleepiness Scale
Epworth Sleepiness Scale
Measured: After 14 days per treatment
Secondary outcomes (1)
Efficacy Maintenance of Wakefulness Test
Maintenance of Wakefulness Test
Measured: After 14 days per treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypersomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balance Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Lien, PhD, Study director, Balance Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512588
- Sponsor's protocol ID
- BTD-001 IH201
- Status last verified
- Jan 2019
- First submitted
- 23 Jul 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02512588
- Acronym / sponsor ID
- BTD-001 IH201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Balance TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTD-001 | Experimental | Drug: BTD-001 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTD-001 | Drug | BTD-001 |
| Placebo | Drug | Placebo |
Primary outcome
Efficacy Epworth Sleepiness Scale
Time frame: After 14 days per treatment
Epworth Sleepiness Scale
1 secondary outcome
Efficacy Maintenance of Wakefulness Test
Time frame: After 14 days per treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Lien, PhD study director
Balance Therapeutics, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTD-001 in people with Idiopathic Hypersomnia and Narcolepsy Without Cataplexy, run by Balance Therapeutics at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Epworth Sleepiness Scale (time frame: After 14 days per treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.