Clinical trial NCT04072380: A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline in the mean total ESS score at Day 14
Secondary outcomes:
measure: Clinical Global Impression of Severity
timeFrame: Change from baseline in the mean CGI-S score at Day 14
measure: Maintenance of Wakefulness Test
timeFrame: Change from baseline in the mean MWT score at Day 14
Other outcomes:
measure: Patient Global Impression of Change
timeFrame: Analysis of Patient Global Impression of Change (PGI-C) at Day 14
measure: Clinical Global Impression of Change
timeFrame: Analysis of Clinical Global Impression of Change (CGI-C) at Day 14
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center o f Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Southern California Institute for Respiratory Diseases, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc.
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials Inc.
state: California
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Kissimmee
country: United States
facility: PDS Research
state: Florida
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida, PA
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Winter Park
country: United States
facility: Florida Pediatric Research Institute
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Gainesville
country: United States
facility: The Neuro Center
state: Georgia
city: Lawrenceville
country: United States
facility: IACT Health
state: Georgia
city: Macon
country: United States
facility: Sleep Practitioners, LLC
state: Georgia
city: Rincon
country: United States
facility: IACT Health
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute
state: Georgia
city: Chevy Chase
country: United States
facility: Helene A. Emsellem, MD PC
state: Maryland
city: Portage
country: United States
facility: Bronson Sleep Health
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services
state: Michigan
city: Chesterfield
country: United States
facility: St Lukes Hospital, Sleep Medicine & Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Canton
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research, LLC
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic, Sleep Disorders Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Wyomissing
country: United States
facility: Respiratory Specialists
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Lung Critical Care
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
city: San Antonio
country: United States
facility: Roadrunner Research
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Toronto
country: Canada
facility: Jodha Tishon Inc
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.