Trial · NCT04072380

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

NCT04072380, Phase 2, Completed, Suven Life Sciences Limited; results first posted 2025-01-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy. Trials, record NCT04072380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04072380

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
NCT number: NCT04072380
Status: Completed
Phases: Phase 2
Enrollment: 190 participants, actual
Lead sponsor: Suven Life Sciences Limited
Conditions: Narcolepsy
Interventions: SUVN-G3031, Placebo
First posted: 2019-08-28
Last updated: 2025-01-13
Results first posted: 2025-01-13

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Other	Patient Global Impression of Change	Analysis of Patient Global Impression of Change (PGI-C) at Day 14	The PGI-C is based on a 7-point scale, where at each time point the patient will rate the change from baseline using the following query: "Since the start of the study, my overall status is: 1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 6 = much worse; 7 = very much worse." The PGI-C assessment will be based on change observed from baseline related to excessive daytime sleepiness rather than on the totality of the disease.
Other	Clinical Global Impression of Change	Analysis of Clinical Global Impression of Change (CGI-C) at Day 14	The CGI-C is based on a 7-point scale, where at each time point the physician will rate the change from baseline using the following query: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1 = very much improved since the initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline (the initiation of treatment); 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment." The CGI-C assessment will be based on change observed from baseline related to excessive daytime sleepiness rather than on the totality of the disease.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Epworth Sleepiness Scale	Change from baseline in the mean total ESS score at Day 14	Intent to treat (ITT) population is considered for outcome measure.	score on a scale	MEAN
SECONDARY	Clinical Global Impression of Severity	Change from baseline in the mean CGI-S score at Day 14	Intent to treat (ITT) population is considered for outcome measure.	score on a scale	MEAN
SECONDARY	Maintenance of Wakefulness Test	Change from baseline in the mean MWT score at Day 14	Intent to treat (ITT) population is considered for outcome measure.	minutes	MEAN
OTHER_PRE_SPECIFIED	Patient Global Impression of Change	Analysis of Patient Global Impression of Change (PGI-C) at Day 14	Intent to treat (ITT) population is considered for outcome measure.	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Clinical Global Impression of Change	Analysis of Clinical Global Impression of Change (CGI-C) at Day 14	Intent to treat (ITT) population is considered for outcome measure.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Epworth Sleepiness Scale	SUVN-G3031 2mg	-5.1	Standard Deviation 5.00	score on a scale
Epworth Sleepiness Scale	SUVN-G3031 4mg	-5.6	Standard Deviation 5.46	score on a scale
Epworth Sleepiness Scale	Placebo	-3.3	Standard Deviation 4.61	score on a scale
Clinical Global Impression of Severity	SUVN-G3031 2mg	-1.2	Standard Deviation 1.24	score on a scale
Clinical Global Impression of Severity	SUVN-G3031 4mg	-1.4	Standard Deviation 1.19	score on a scale
Clinical Global Impression of Severity	Placebo	-0.8	Standard Deviation 1.17	score on a scale
Maintenance of Wakefulness Test	SUVN-G3031 2mg	2.07	Standard Deviation 4.68	minutes
Maintenance of Wakefulness Test	SUVN-G3031 4mg	4.25	Standard Deviation 6.52	minutes
Maintenance of Wakefulness Test	Placebo	2.73	Standard Deviation 7.00	minutes
Patient Global Impression of Change	SUVN-G3031 2mg	3.2	Standard Deviation 1.16	score on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SUVN-G3031 2mg	63
Overall Study	STARTED	SUVN-G3031 4mg	64
Overall Study	STARTED	Placebo	63
Overall Study	Safety Population	SUVN-G3031 2mg	63
Overall Study	Safety Population	SUVN-G3031 4mg	63
Overall Study	Safety Population	Placebo	62
Overall Study	Intent-to-treat (ITT) Population	SUVN-G3031 2mg	54
Overall Study	Intent-to-treat (ITT) Population	SUVN-G3031 4mg	53
Overall Study	Intent-to-treat (ITT) Population	Placebo	57
Overall Study	COMPLETED	SUVN-G3031 2mg	51

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Insomnia	Psychiatric disorders	SUVN-G3031 2mg	6	63	7
other	Insomnia	Psychiatric disorders	SUVN-G3031 4mg	11	63	11
other	Insomnia	Psychiatric disorders	Placebo	2	62	2
other	Abnormal dreams	Psychiatric disorders	SUVN-G3031 2mg	3	63	3
other	Abnormal dreams	Psychiatric disorders	SUVN-G3031 4mg	5	63	6
other	Abnormal dreams	Psychiatric disorders	Placebo	0	62	0
other	Nausea	Gastrointestinal disorders	SUVN-G3031 2mg	5	63	6
other	Nausea	Gastrointestinal disorders	SUVN-G3031 4mg	11	63	13
other	Nausea	Gastrointestinal disorders	Placebo	2	62	2
other	Hot flush	Vascular disorders	SUVN-G3031 2mg	3	63	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SUVN-G3031 2mg	0	63
Total, all-cause mortality	SUVN-G3031 4mg	0	63
Total, all-cause mortality	Placebo	0	62
Total, other adverse events	SUVN-G3031 2mg	17	63
Total, other adverse events	SUVN-G3031 4mg	34	63
Total, other adverse events	Placebo	5	62
Total, serious adverse events	SUVN-G3031 2mg	0	63
Total, serious adverse events	SUVN-G3031 4mg	0	63
Total, serious adverse events	Placebo	0	62

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32399853	DERIVED	PubMed
39504585	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04072380/registered

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