At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 190 enrolled
Drug / intervention
SUVN-G3031 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SUVN-G3031 and Placebo for Narcolepsy. Completed, enrolled 190 participants across 41 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2019
Primary CompletionJun 2023
Study CompletionJun 2023
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartSep 21, 2019
Primary CompletionJun 7, 2023
Study CompletionJun 13, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.8 years ago
Interventions
SUVN-G3031drug
SUVN-G3031 Tablets
Placebodrug
Placebo Tablets