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

NCT ID: NCT04072380

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-21
• Study Completion Date: 2023-06-13

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.

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.

Conditions

Narcolepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SUVN-G3031 2mg

Orally taken once daily for 14 days

Group Type: EXPERIMENTAL

SUVN-G3031

Intervention Type: DRUG

SUVN-G3031 Tablets

SUVN-G3031 4mg

Orally taken once daily for 14 days

Group Type: EXPERIMENTAL

SUVN-G3031

Intervention Type: DRUG

SUVN-G3031 Tablets

Placebo

Orally taken once daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Tablets

Interventions

SUVN-G3031

SUVN-G3031 Tablets

Intervention Type: DRUG

Placebo

Placebo Tablets

Intervention Type: DRUG

Other Intervention Names

Samelisant

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suven Life Sciences Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sleep Disorders Center o f Alabama

Birmingham, Alabama, United States

Santa Monica Clinical Trials

Los Angeles, California, United States

Southern California Institute for Respiratory Diseases, Inc.

Los Angeles, California, United States

Pacific Research Network, Inc.

San Diego, California, United States

SDS Clinical Trials Inc.

Santa Ana, California, United States

Meris Clinical Research

Brandon, Florida, United States

Teradan Clinical Trials

Brandon, Florida, United States

St. Francis Medical Institute

Clearwater, Florida, United States

PDS Research

Kissimmee, Florida, United States

Sleep Medicine Specialists of South Florida, PA

Miami, Florida, United States

Ivetmar Medical Group, LLC

Miami, Florida, United States

Florida Pediatric Research Institute

Winter Park, Florida, United States

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States

NeuroTrials Research Inc

Atlanta, Georgia, United States

The Neuro Center

Gainesville, Georgia, United States

IACT Health

Lawrenceville, Georgia, United States

Sleep Practitioners, LLC

Macon, Georgia, United States

IACT Health

Rincon, Georgia, United States

Clinical Research Institute

Stockbridge, Georgia, United States

Helene A. Emsellem, MD PC

Chevy Chase, Maryland, United States

Bronson Sleep Health

Portage, Michigan, United States

Clinical Neurophysiology Services

Sterling Heights, Michigan, United States

St Lukes Hospital, Sleep Medicine & Research Center

Chesterfield, Missouri, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Research Carolina Elite

Denver, North Carolina, United States

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Ohio Sleep Medicine Institute

Canton, Ohio, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Intrepid Research, LLC

Cincinnati, Ohio, United States

Cleveland Clinic, Sleep Disorders Center

Cleveland, Ohio, United States

Ohio Sleep Medicine Institute

Dublin, Ohio, United States

Respiratory Specialists

Wyomissing, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Bogan Sleep Consultants

Columbia, South Carolina, United States

Lowcountry Lung Critical Care

North Charleston, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States

Roadrunner Research

San Antonio, Texas, United States

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Medical Arts Health Research Group

Kelowna, British Columbia, Canada

Jodha Tishon Inc

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 39504585 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32399853 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTP2S13031H3

Identifier Type: -

Identifier Source: org_study_id