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Completed

NCT Number: NCT04072380

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

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.

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Key information

Conditions

Narcolepsy Cataplexy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Arts Health Research Group, Kelowna, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

SUVN-G3031

Drug

SUVN-G3031 Tablets

Other names: Samelisant

Placebo

Drug

Placebo Tablets

Primary outcomes

  1. Epworth Sleepiness Scale

    Time frame: Change from baseline in the mean total ESS score at Day 14

    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.

Secondary outcomes

  1. Clinical Global Impression of Severity

    Time frame: Change from baseline in the mean CGI-S score at Day 14

    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.

  2. Maintenance of Wakefulness Test

    Time frame: Change from baseline in the mean MWT score at Day 14

    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.

Other outcomes

  1. Patient Global Impression of Change

    Time frame: Analysis of Patient Global Impression of Change (PGI-C) at Day 14

    The PGI-C is based on a 7-point scale, where at each time point the patient will rate the change from baseline using the following query: "Since the start of the study, my overall status is: 1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 6 = much worse; 7 = very much worse." The PGI-C assessment will be based on change observed from baseline related to excessive daytime sleepiness rather than on the totality of the disease.

  2. Clinical Global Impression of Change

    Time frame: Analysis of Clinical Global Impression of Change (CGI-C) at Day 14

    The CGI-C is based on a 7-point scale, where at each time point the physician will rate the change from baseline using the following query: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1 = very much improved since the initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline (the initiation of treatment); 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment." The CGI-C assessment will be based on change observed from baseline related to excessive daytime sleepiness rather than on the totality of the disease.

Sponsors and collaborators

Lead sponsor

Suven Life Sciences Limited

Industry

Registry information

Official study title

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

Acronym: SUVN-G3031

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2019
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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