Phase 2
N=190
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT04072380 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Epworth Sleepiness Scale — -5.1; -5.6; -3.3 score on a scale — p=0.024
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SUVN-G3031 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Suven Life Sciences Limited
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epworth Sleepiness Scale |
-5.1; -5.6; -3.3 | 0.024 sig |
| SECONDARY Clinical Global Impression of Severity |
-1.2; -1.4; -0.8 | 0.009 sig |
| SECONDARY Maintenance of Wakefulness Test |
2.07; 4.25; 2.73 | 0.734 |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT04072380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.