A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
- Registration Number
- NCT04072380
- Lead Sponsor
- Suven Life Sciences Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SUVN-G3031 4mg SUVN-G3031 Orally taken once daily for 14 days Placebo Placebo Orally taken once daily for 14 days SUVN-G3031 2mg SUVN-G3031 Orally taken once daily for 14 days
- Primary Outcome Measures
Name Time Method Epworth Sleepiness Scale Change from baseline in the mean total ESS score at Day 14 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.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression of Severity Change from baseline in the mean CGI-S score at Day 14 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.
Maintenance of Wakefulness Test Change from baseline in the mean MWT score at Day 14 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.
Trial Locations
- Locations (39)
Santa Monica Clinical Trials
🇺🇸Los Angeles, California, United States
Southern California Institute for Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Sleep Medicine Specialists of South Florida, PA
🇺🇸Miami, Florida, United States
Lowcountry Lung Critical Care
🇺🇸North Charleston, South Carolina, United States
SDS Clinical Trials Inc.
🇺🇸Santa Ana, California, United States
PDS Research
🇺🇸Kissimmee, Florida, United States
Florida Pulmonary Research Institute, LLC
🇺🇸Winter Park, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Sleep Practitioners, LLC
🇺🇸Macon, Georgia, United States
Cleveland Clinic, Sleep Disorders Center
🇺🇸Cleveland, Ohio, United States
Florida Pediatric Research Institute
🇺🇸Winter Park, Florida, United States
Intrepid Research, LLC
🇺🇸Cincinnati, Ohio, United States
Helene A. Emsellem, MD PC
🇺🇸Chevy Chase, Maryland, United States
Clayton Sleep Institute
🇺🇸Saint Louis, Missouri, United States
Research Carolina Elite
🇺🇸Denver, North Carolina, United States
Clinical Neurophysiology Services
🇺🇸Sterling Heights, Michigan, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
St Lukes Hospital, Sleep Medicine & Research Center
🇺🇸Chesterfield, Missouri, United States
Clinical Research Institute
🇺🇸Stockbridge, Georgia, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States
Roadrunner Research
🇺🇸San Antonio, Texas, United States
Sleep Disorders Center o f Alabama
🇺🇸Birmingham, Alabama, United States
Teradan Clinical Trials
🇺🇸Brandon, Florida, United States
Meris Clinical Research
🇺🇸Brandon, Florida, United States
Ivetmar Medical Group, LLC
🇺🇸Miami, Florida, United States
Pacific Research Network, Inc.
🇺🇸San Diego, California, United States
The Neuro Center
🇺🇸Gainesville, Georgia, United States
IACT Health
🇺🇸Rincon, Georgia, United States
Bronson Sleep Health
🇺🇸Portage, Michigan, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
Respiratory Specialists
🇺🇸Wyomissing, Pennsylvania, United States
Bogan Sleep Consultants
🇺🇸Columbia, South Carolina, 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
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States