A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.

Official Title
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A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy

Conditions
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Narcolepsy

Intervention / Treatment
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* Drug: SUVN-G3031
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 ESS score of ≥ 12; and mean 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 to cause sleep disruption or any other cause of daytime sleepiness. Clinically significant ECG abnormalities. An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts sleep patterns.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUVN-G3031 2mg<br>Orally taken once daily for 14 days | Drug: SUVN-G3031<br>* SUVN-G3031 Tablets<br>* Other names: Samelisant;|
| Experimental: SUVN-G3031 4mg<br>Orally taken once daily for 14 days | Drug: SUVN-G3031<br>* SUVN-G3031 Tablets<br>* Other names: Samelisant;|
| Placebo Comparator: Placebo<br>Orally taken once daily for 14 days | Drug: Placebo<br>* Placebo Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale (ESS) | The Epworth Sleepiness Scale (ESS) is a patient-reported questionnaire consisting of 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. Higher values represent a worse outcome. | Change from baseline in the mean total ESS score at Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Severity (CGI-S) | The Clinical Global Impressions of Severity (CGI-S) scale is used to rate the severity of the patient's illness by clinician, on a 7-point scale with score ranging from 1 - 7. Higher values represent a worse outcome. | Change from baseline in the mean CGI-S score at Day 14 | 
| Maintenance of Wakefulness Test (MWT) | Maintenance of Wakefulness Test (MWT) is an objective test of sleepiness that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. In the MWT, time from start of the test to the time point of falling asleep will be measured, the total score can range from 0 - 30 minutes. Higher values represent a better outcome. | Change from baseline in the mean MWT score at Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUVN-G3031, Narcolepsy with and without cataplexy, Cataplexy, Narcolepsy Type 1, Narcolepsy Type 2, Excessive Daytime Sleepiness (EDS), Histamine H3 receptor, Samelisant