A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (I… (NCT02512588) | Clinical Trial Compass
CompletedPhase 2
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
United States120 participantsStarted 2015-09
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.