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

Sponsor
Suven Life Sciences Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04072380
Collaborator
(none)
171
Enrollment
41
Locations
3
Arms
42.3
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 21, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SUVN-G3031 2mg

Orally taken once daily for 14 days

Drug: SUVN-G3031
SUVN-G3031 Tablets
Other Names:
  • Samelisant

    		•
    Experimental: SUVN-G3031 4mg

    Orally taken once daily for 14 days

    Drug: SUVN-G3031
    SUVN-G3031 Tablets
    Other Names:
  • Samelisant

    		•
    Placebo Comparator: Placebo

    Orally taken once daily for 14 days

    Drug: Placebo
    Placebo Tablets

    Outcome Measures

    Primary Outcome Measures

    1. Maintenance of Wakefulness Test (MWT) [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.

    Secondary Outcome Measures

    1. Clinical Global Impression of Severity (CGI-S) [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. Epworth Sleepiness Scale (ESS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sleep Disorders Center o f Alabama Birmingham Alabama United States 35213
    2 Mayo Clinic Arizona Phoenix Arizona United States 85054
    3 Southern California Institute for Respiratory Diseases, Inc. Los Angeles California United States 90048
    4 Pacific Research Network, Inc. San Diego California United States 92103
    5 SDS Clinical Trials Inc. Santa Ana California United States 92705
    6 Santa Monica Clinical Trials Santa Monica California United States 90404
    7 Meris Clinical Research Brandon Florida United States 33511
    8 Teradan Clinical Trials Brandon Florida United States 33511
    9 St. Francis Medical Institute Clearwater Florida United States 33765
    10 PDS Research Kissimmee Florida United States 34741
    11 Sleep Medicine Specialists of South Florida, PA Miami Florida United States 33126
    12 Ivetmar Medical Group, LLC Miami Florida United States 33155
    13 Florida Pediatric Research Institute Winter Park Florida United States 32789
    14 Florida Pulmonary Research Institute, LLC Winter Park Florida United States 32789
    15 NeuroTrials Research Inc Atlanta Georgia United States 30342
    16 The Neuro Center Gainesville Georgia United States 30501
    17 IACT Health Lawrenceville Georgia United States 30045
    18 Sleep Practitioners, LLC Macon Georgia United States 31210
    19 IACT Health Rincon Georgia United States 31326
    20 Clinical Research Institute Stockbridge Georgia United States 30281
    21 Helene A. Emsellem, MD PC Chevy Chase Maryland United States 20815
    22 Bronson Sleep Health Portage Michigan United States 49024
    23 Clinical Neurophysiology Services Sterling Heights Michigan United States 48314
    24 St Lukes Hospital, Sleep Medicine & Research Center Chesterfield Missouri United States 63017
    25 Clayton Sleep Institute Saint Louis Missouri United States 63123
    26 Research Carolina Elite Denver North Carolina United States 28078
    27 Clinical Research of Gastonia Gastonia North Carolina United States 28054
    28 Ohio Sleep Medicine Institute Canton Ohio United States 44718
    29 CTI Clinical Research Center Cincinnati Ohio United States 45212
    30 Intrepid Research, LLC Cincinnati Ohio United States 45245
    31 Cleveland Clinic, Sleep Disorders Center Cleveland Ohio United States 44195
    32 Ohio Sleep Medicine Institute Dublin Ohio United States 43017
    33 IPS Research Company Oklahoma City Oklahoma United States 73106
    34 Respiratory Specialists Wyomissing Pennsylvania United States 19610
    35 Bogan Sleep Consultants Columbia South Carolina United States 29201
    36 Lowcountry Lung Critical Care North Charleston South Carolina United States 29406
    37 FutureSearch Trials of Neurology Austin Texas United States 78731
    38 Sleep Therapy & Research Center San Antonio Texas United States 78229
    39 Roadrunner Research San Antonio Texas United States 78249
    40 Children's Hospital of the King's Daughters Norfolk Virginia United States 23507
    41 Jodha Tishon Inc Toronto Ontario Canada M5S 3A3

    Sponsors and Collaborators

    • Suven Life Sciences Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suven Life Sciences Limited
    ClinicalTrials.gov Identifier:
    NCT04072380
    Other Study ID Numbers:
    • CTP2S13031H3
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Suven Life Sciences Limited
    SUVN-G3031
    Narcolepsy with and without cataplexy
    Cataplexy
    Narcolepsy Type 1
    Narcolepsy Type 2
    Excessive Daytime Sleepiness (EDS)
    Histamine H3 receptor
    Samelisant
    Additional relevant MeSH terms:
    Narcolepsy
    Cataplexy

    Study Results

    No Results Posted as of Apr 14, 2022