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

Narcolepsy Clinical Trial

— SUVN-G3031  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072380
• Other study ID #: CTP2S13031H3
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2019
• Est. completion date: June 13, 2023

Study information

• Verified date: October 2023
• Source: Suven Life Sciences Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 13, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataplexy
• Narcolepsy

Intervention

Drug:
• SUVN-G3031
SUVN-G3031 Tablets
• Placebo
Placebo Tablets

Locations

Country	Name	City	State
Canada	Medical Arts Health Research Group	Kelowna	British Columbia
Canada	Jodha Tishon Inc	Toronto	Ontario
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Sleep Disorders Center o f Alabama	Birmingham	Alabama
United States	Meris Clinical Research	Brandon	Florida
United States	Teradan Clinical Trials	Brandon	Florida
United States	Ohio Sleep Medicine Institute	Canton	Ohio
United States	Medical University of South Carolina	Charleston	South Carolina
United States	St Lukes Hospital, Sleep Medicine & Research Center	Chesterfield	Missouri
United States	Helene A. Emsellem, MD PC	Chevy Chase	Maryland
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Intrepid Research, LLC	Cincinnati	Ohio
United States	St. Francis Medical Institute	Clearwater	Florida
United States	Cleveland Clinic, Sleep Disorders Center	Cleveland	Ohio
United States	Bogan Sleep Consultants	Columbia	South Carolina
United States	Research Carolina Elite	Denver	North Carolina
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	The Neuro Center	Gainesville	Georgia
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	PDS Research	Kissimmee	Florida
United States	IACT Health	Lawrenceville	Georgia
United States	Santa Monica Clinical Trials	Los Angeles	California
United States	Southern California Institute for Respiratory Diseases, Inc.	Los Angeles	California
United States	Sleep Practitioners, LLC	Macon	Georgia
United States	Ivetmar Medical Group, LLC	Miami	Florida
United States	Sleep Medicine Specialists of South Florida, PA	Miami	Florida
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Lowcountry Lung Critical Care	North Charleston	South Carolina
United States	Bronson Sleep Health	Portage	Michigan
United States	IACT Health	Rincon	Georgia
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Roadrunner Research	San Antonio	Texas
United States	Sleep Therapy & Research Center	San Antonio	Texas
United States	Pacific Research Network, Inc.	San Diego	California
United States	SDS Clinical Trials Inc.	Santa Ana	California
United States	Clinical Neurophysiology Services	Sterling Heights	Michigan
United States	Clinical Research Institute	Stockbridge	Georgia
United States	Florida Pediatric Research Institute	Winter Park	Florida
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida
United States	Respiratory Specialists	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Suven Life Sciences Limited

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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