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 States190 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 range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Epworth Sleepiness Scale
Timeframe: Change from baseline in the mean total ESS score at Day 14