Idiopathic HypersomniaPhase 2ARISE2NCT03542851
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
A Phase 2 study testing Pentetrazol (PTZ) in people with Idiopathic Hypersomnia, run by Balance Therapeutics at 32 sites in United States.
Trial summary
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- Pentetrazol (PTZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 32 sitesUnited States
- Study dates
- 29 May 2018to 28 May 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
NeuroTrials Research Inc.
Atlanta, Georgia, 30342
Future Search Trials
Austin, Texas, 78731
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
REM Sleep Medicine
Boulder, Colorado, 80301
PAB Clinical Research
Brandon, Florida, 33511
St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri, 63017
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Intrepid Research
Cincinnati, Ohio, 95242
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Geisinger
Danville, Pennsylvania, 17822
Fort Wayne Neurology
Fort Wayne, Indiana, 46804
Houston Sleep Center
Houston, Texas, 77063
Research Carolina of Huntersville
Huntersville, North Carolina, 28078
Rowe Neurology Institute
Lenexa, Kansas, 66214
Kentucky Research Group
Louisville, Kentucky, 40218
Sleep Practicioners
Macon, Georgia, 31210
Sleep Medicine Specialists of South Florida
Miami, Florida, 33126
Consolidated Clinical Trials
Monroeville, Pennsylvania, 15146
Columbia University - Department of Neurology
New York, New York, 10032
Albert Einstein College of Medicine
New York, New York, 10467
NeuroCare
Newton, Massachusetts, 02459
Northshore Sleep Medicine
Northbrook, Illinois, 60062
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
SDS Clinical Trials
Orange, California, 92868
Neuroscience Center
Saint Paul, Minnesota, 55130
Pacific Research Network
San Diego, California, 92128
Sleep Medicine Specialists of California
San Ramon, California, 94583
Santa Monica Clinical Trials
Santa Monica, California, 90404
Mayo Clinic Hospital
Scottsdale, Arizona, 85054
Swedish Medical Center
Seattle, Washington, 98122
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, 48314
Florida Premier Research Institute
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
Read the 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.
- Conditions
- Idiopathic Hypersomnia
- Being tested
- Pentetrazol (PTZ), Placebo oral capsule
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentetrazol (PTZ)Drug
Also called PTZ
BTD-001 is an oral capsule of PTZ.
Placebo oral capsuleDrug
Placebo will be presented as oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| Subject Receives BTD001 first | Experimental | Not described Receives: Drug: Pentetrazol (PTZ); Drug: Placebo oral capsule |
| Subject Receives Placebo first | Experimental | Not described Receives: Drug: Pentetrazol (PTZ); Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Measurements: IH Symptom Diary.
Measured: Change from baseline.
Secondary outcomes (2)
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Measurements: ESS (Epworth Sleepiness Scale).
Measured: Change from baseline.
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Measurements: MWT (Maintenance of Wakefulness Test)
Measured: Change from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start29 May 2018
- Primary completion1 May 2020 (estimated)
- Study completion28 May 2020 (estimated)
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balance Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Morgan Lam, Study director, Chief Operating Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542851
- Sponsor's protocol ID
- BTD-001 IH202
- Acronym
- ARISE2
- Status last verified
- Apr 2020
- First submitted
- 1 May 2018
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
- ClinicalTrials.gov ID
- NCT03542851
- Acronym / sponsor ID
- ARISE2 / BTD-001 IH202
- Conditions
- Idiopathic Hypersomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Balance TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 28 May 2020 (estimated)
- First posted
- 31 May 2018 (actual)
- 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject Receives BTD001 first | Experimental | Drug: Pentetrazol (PTZ), Drug: Placebo oral capsule |
| Subject Receives Placebo first | Experimental | Drug: Pentetrazol (PTZ), Drug: Placebo oral capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Pentetrazol (PTZ)Also: PTZBTD-001 is an oral capsule of PTZ. | Drug | Subject Receives BTD001 first, Subject Receives Placebo first |
| Placebo oral capsulePlacebo will be presented as oral capsule. | Drug | Subject Receives BTD001 first, Subject Receives Placebo first |
Primary outcome
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Time frame: Change from baseline.
Measurements: IH Symptom Diary.
2 secondary outcomes
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Time frame: Change from baseline.
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Time frame: Change from baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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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.
Morgan Lam study director
Chief Operating Officer
32 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 Pentetrazol (PTZ) in people with Idiopathic Hypersomnia, run by Balance Therapeutics at 32 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Results are not available in the source record.
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?
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary (time frame: Change from baseline.). 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 29 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.