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

NCT04072380 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CTP2S13031H3
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 41

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.

Conditions

Narcolepsy

Keywords

SUVN-G3031; Narcolepsy with and without cataplexy; Cataplexy; Narcolepsy Type 1; Narcolepsy Type 2; Excessive Daytime Sleepiness (EDS); Histamine H3 receptor; Samelisant

Outcome Measures

Primary Outcomes (1)

• Epworth Sleepiness Scale

  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 Outcomes (2)

• Clinical Global Impression of Severity

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

• Maintenance of Wakefulness Test

  Change from baseline in the mean MWT score at Day 14

Other Outcomes (2)

• Patient Global Impression of Change

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

• Clinical Global Impression of Change

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

Study Arms (3)

SUVN-G3031 2mg

EXPERIMENTAL

Orally taken once daily for 14 days

Drug: SUVN-G3031

SUVN-G3031 4mg

EXPERIMENTAL

Orally taken once daily for 14 days

Drug: SUVN-G3031

Placebo

PLACEBO COMPARATOR

Orally taken once daily for 14 days

Drug: Placebo

Interventions

SUVN-G3031 DRUG

SUVN-G3031 Tablets

Also known as: Samelisant

SUVN-G3031 2mg; SUVN-G3031 4mg

Placebo DRUG

Placebo Tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

Study Sites (41)

Sleep Disorders Center o f Alabama

Birmingham, Alabama, 35213, United States

Location

Santa Monica Clinical Trials

Los Angeles, California, 90025, United States

Location

Southern California Institute for Respiratory Diseases, Inc.

Los Angeles, California, 90048-6138, United States

Location

Pacific Research Network, Inc.

San Diego, California, 92103, United States

Location

SDS Clinical Trials Inc.

Santa Ana, California, 92705, United States

Location

Meris Clinical Research

Brandon, Florida, 33511, United States

Location

Teradan Clinical Trials

Brandon, Florida, 33511, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

PDS Research

Kissimmee, Florida, 34741, United States

Location

Sleep Medicine Specialists of South Florida, PA

Miami, Florida, 33126, United States

Location

Ivetmar Medical Group, LLC

Miami, Florida, 33155, United States

Location

Florida Pediatric Research Institute

Winter Park, Florida, 32789, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30342, United States

Location

The Neuro Center

Gainesville, Georgia, 30501, United States

Location

IACT Health

Lawrenceville, Georgia, 30045, United States

Location

Sleep Practitioners, LLC

Macon, Georgia, 31210, United States

Location

IACT Health

Rincon, Georgia, 31326, United States

Location

Clinical Research Institute

Stockbridge, Georgia, 30281, United States

Location

Helene A. Emsellem, MD PC

Chevy Chase, Maryland, 20815, United States

Location

Bronson Sleep Health

Portage, Michigan, 49024, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

St Lukes Hospital, Sleep Medicine & Research Center

Chesterfield, Missouri, 63017, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Research Carolina Elite

Denver, North Carolina, 28078, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

Ohio Sleep Medicine Institute

Canton, Ohio, 44718, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Intrepid Research, LLC

Cincinnati, Ohio, 45245, United States

Location

Cleveland Clinic, Sleep Disorders Center

Cleveland, Ohio, 44195, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Respiratory Specialists

Wyomissing, Pennsylvania, 19610, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

Lowcountry Lung Critical Care

North Charleston, South Carolina, 29406, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

Roadrunner Research

San Antonio, Texas, 78249, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Medical Arts Health Research Group

Kelowna, British Columbia, V1Y 4N7, Canada

Location

Jodha Tishon Inc

Toronto, Ontario, M5S 3A3, Canada

Location

Related Publications (2)

• Nirogi R, Shinde A, Goyal VK, Ravula J, Benade V, Jetta S, Pandey SK, Subramanian R, Chowdary Palacharla VR, Mohammed AR, Abraham R, Dogiparti DK, Kalaikadhiban I, Jayarajan P, Jasti V, Bogan RK. Samelisant (SUVN-G3031), a histamine 3 receptor inverse agonist: Results from the phase 2 double-blind randomized placebo-controlled study for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Sleep Med. 2024 Dec;124:618-626. doi: 10.1016/j.sleep.2024.10.037. Epub 2024 Oct 30.

  PMID: 39504585 RESULT

• 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.

  PMID: 32399853 DERIVED

MeSH Terms

Conditions

Narcolepsy; Cataplexy; Disorders of Excessive Somnolence

Interventions

samelisant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Ramakrishna Nirogi, PhD
• Organization: Suven Life Sciences

nvsrk@suven.com

+9140 2319 3956

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: September 21, 2019
• Primary Completion: June 7, 2023
• Study Completion: June 13, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (39)