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

Completed · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy

In brief

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.

Key facts

Study ID

NCT04072380

Run by

Suven Life Sciences Limited

People needed

190

Starts

2019-09-21

Expected to finish

2023-06-13

Last updated by the study team

2025-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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