A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy W… (NCT04072380) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
United States, Canada190 participantsStarted 2019-09-21
Plain-language summary
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.
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:
* Ages of 18 to 65 years (adult), inclusive.
* Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed).
* Have undergone a multiple sleep latency test (MSLT) study showing an MSLT of ≤ 8 minutes.
* An Epworth Sleepiness Scale (ESS) score of ≥ 12; and mean Maintenance of Wakefulness Test (MWT) time of \< 12 min.
* Body mass index ranging from 18 to \< 45 kg/m2
* Negative urine drug screen.
* A woman must be either not of childbearing potential or of childbearing potential practicing highly effective methods of birth control.
* Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form (ICF).
Exclusion Criteria:
* Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of \< 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
* Use of any investigational therapy within the 30-day period prior to enrollment.
* Excessive caffeine (defined as \> 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial.
* Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke).
* Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate.
* Current diagnosis of or past treatment for syndromes known…
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.
What they're measuring
1
Epworth Sleepiness Scale
Timeframe: Change from baseline in the mean total ESS score at Day 14