A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (NCT07540364) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy
240 participantsStarted 2026-06-19
Plain-language summary
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Body mass index ranging from 18 to 45 kg/m2 (both inclusive).
✓. Narcolepsy with or without cataplexy (Narcolepsy Type 1 \[NT1\] or Narcolepsy Type 2 \[NT2\]) based on the International Classification of Sleep Disorders 3-TR/ Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for the diagnosis of narcolepsy.
✓. For NT1 only, current continuing presence of cataplexy as defined by participant report for the last 3 months and have average of ≥4 weekly cataplexy events during the last 2 weeks of the washout period.
✓. At the screening Visit and the Baseline Visit, participants who are not on treatment for EDS must have ESS scores ≥12 (as assessed with a look-back period of 1 week).
✓. A mean MWT time of \<12 minutes across the first 4 sessions at Baseline.
✓. Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form.
✓. Able to show compliance with sleep diary entries for at least 5 times/week in the final 2 weeks of the screening Period (non-compliant participants will not be included).
Exclusion criteria
✕. Median habitual wake-up time after 9 am as assessed by sleep diary, habitual sleep time of \<6 h and median habitual bedtime past 1 am, as determined by sleep diary entries.
✕. Use of any investigational therapy within the 30-day period (or 5 half-lives, whichever is longer) prior to enrollment.
✕
What they're measuring
1
Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12
. History of (within past 3 months) or current substance use disorder involving illicit drugs, alcohol, or marijuana, as per DSM-5-TR criteria. Alcohol and/or recreational drugs use within 24 hours of study visits is strictly prohibited.
✕. Excessive caffeine (defined as \>600 mg/day) use at least 1 week prior to Baseline assessments and during the study.
✕. Nicotine dependence that affects sleep (eg, a participant who routinely awakens at night to smoke).
✕. If receiving stimulants, modafinil, oxybates, pitolisant, solriamfetol, bupropion or other treatments for narcolepsy, and unwilling or unable to complete weaning 2 weeks prior to Baseline visit (Day 1)
✕. Clinically significant ECG abnormalities. Participants are excluded with a screening ECG Fridericia's correction of QT (QTcF) interval ≥450 msec for men and ≥470 msec for women obtained after 5-minute rest in a supine position using a digital ECG.
✕. Concurrent use of hypnotics, tranquilizers, centrally acting H1 receptor antagonists, benzodiazepines, anticonvulsants, or clonidine, tricyclic antidepressants that have H1-antihistamine properties (clomipramine, protriptyline).