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

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

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.

Study Overview

• Status: Completed
• Conditions: Narcolepsy
• Intervention / Treatment: Drug: SUVN-G3031; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: +9140 2319 3956; Email: narcolepsy@suven.com

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 4N7
      • Medical Arts Health Research Group
  • Ontario
    • Toronto, Ontario, Canada, M5S 3A3
      • Jodha Tishon Inc
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center o f Alabama
  • California
    • Los Angeles, California, United States, 90025
      • Santa Monica Clinical Trials
    • Los Angeles, California, United States, 90048-6138
      • Southern California Institute For Respiratory Diseases, Inc.
    • San Diego, California, United States, 92103
      • Pacific Research Network, Inc.
    • Santa Ana, California, United States, 92705
      • SDS Clinical Trials Inc.
  • Florida
    • Brandon, Florida, United States, 33511
      • Meris Clinical Research
    • Brandon, Florida, United States, 33511
      • Teradan Clinical Trials
    • Clearwater, Florida, United States, 33765
      • St. Francis Medical Institute
    • Kissimmee, Florida, United States, 34741
      • PDS Research
    • Miami, Florida, United States, 33126
      • Sleep Medicine Specialists of South Florida, PA
    • Miami, Florida, United States, 33155
      • Ivetmar Medical Group, LLC
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
    • Winter Park, Florida, United States, 32789
      • Florida Pediatric Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research Inc
    • Gainesville, Georgia, United States, 30501
      • The Neuro Center
    • Lawrenceville, Georgia, United States, 30045
      • IACT Health
    • Macon, Georgia, United States, 31210
      • Sleep Practitioners, LLC
    • Rincon, Georgia, United States, 31326
      • IACT Health
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Institute
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Helene A. Emsellem, MD PC
  • Michigan
    • Portage, Michigan, United States, 49024
      • Bronson Sleep Health
    • Sterling Heights, Michigan, United States, 48314
      • Clinical Neurophysiology Services
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St Lukes Hospital, Sleep Medicine & Research Center
    • Saint Louis, Missouri, United States, 63123
      • Clayton Sleep Institute
  • North Carolina
    • Denver, North Carolina, United States, 28078
      • Research Carolina Elite
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research of Gastonia
  • Ohio
    • Canton, Ohio, United States, 44718
      • Ohio Sleep Medicine Institute
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45245
      • Intrepid Research, LLC
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Sleep Disorders Center
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Respiratory Specialists
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants
    • North Charleston, South Carolina, United States, 29406
      • Lowcountry Lung Critical Care
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy & Research Center
    • San Antonio, Texas, United States, 78249
      • Roadrunner Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGI-C)	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.	Proportion of subjects with improvement in the PGI-C score from baseline to Day 14
Clinical Global Impression of Change (CGI-C)	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.	Proportion of subjects reporting CGI-C scores of 1 or 2 or 3 at Day 14

Collaborators and Investigators

• Sponsor: Suven Life Sciences Limited

Publications and helpful links

General Publications

• Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2019
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Excessive Daytime Sleepiness (EDS); Cataplexy; SUVN-G3031; Narcolepsy with and without cataplexy; Narcolepsy Type 1; Narcolepsy Type 2; Histamine H3 receptor; Samelisant
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy; Cataplexy
• Other Study ID Numbers: CTP2S13031H3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No