Status:
COMPLETED
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Lead Sponsor:
Suven Life Sciences Limited
Conditions:
Narcolepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 lear...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04072380
Start Date
September 21 2019
End Date
June 13 2023
Last Update
January 13 2025
Active Locations (41)
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1
Sleep Disorders Center o f Alabama
Birmingham, Alabama, United States, 35213
2
Santa Monica Clinical Trials
Los Angeles, California, United States, 90025
3
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States, 90048-6138
4
Pacific Research Network, Inc.
San Diego, California, United States, 92103