Trial Outcomes & Findings for A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy (NCT NCT04072380)
NCT ID: NCT04072380
Last Updated: 2025-01-13
Results Overview
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.
COMPLETED
PHASE2
190 participants
Change from baseline in the mean total ESS score at Day 14
2025-01-13
Participant Flow
Participant milestones
| Measure |
SUVN-G3031 2mg
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
64
|
63
|
|
Overall Study
Safety Population
|
63
|
63
|
62
|
|
Overall Study
Intent-to-treat (ITT) Population
|
54
|
53
|
57
|
|
Overall Study
COMPLETED
|
51
|
50
|
53
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
10
|
Reasons for withdrawal
| Measure |
SUVN-G3031 2mg
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
3
|
|
Overall Study
Intercurrent Illness and Others
|
3
|
5
|
6
|
Baseline Characteristics
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Baseline characteristics by cohort
| Measure |
SUVN-G3031 2mg
n=63 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=63 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=62 Participants
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 9.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
60 participants
n=7 Participants
|
58 participants
n=5 Participants
|
175 participants
n=4 Participants
|
|
Epworth Sleepiness Scale (ESS)
|
17.3 units on a scale
STANDARD_DEVIATION 2.76 • n=5 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 2.84 • n=7 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 3.03 • n=5 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 2.86 • n=4 Participants
|
|
Clinical Global Impression of Severity (CGI-S)
|
4.7 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.83 • n=7 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.83 • n=4 Participants
|
|
Maintenance of Wakefulness Test (MWT)
|
5.166 minutes
STANDARD_DEVIATION 4.466 • n=5 Participants
|
6.141 minutes
STANDARD_DEVIATION 4.073 • n=7 Participants
|
6.242 minutes
STANDARD_DEVIATION 4.158 • n=5 Participants
|
5.846 minutes
STANDARD_DEVIATION 4.243 • n=4 Participants
|
|
Patient Global Impression of Change (PGI-C)
|
4.8 units on a scale
STANDARD_DEVIATION 1.08 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 1.03 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 1.01 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 1.04 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in the mean total ESS score at Day 14Population: Intent to treat (ITT) population is considered for outcome measure.
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.
Outcome measures
| Measure |
SUVN-G3031 2mg
n=54 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=53 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=57 Participants
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Epworth Sleepiness Scale
|
-5.1 score on a scale
Standard Deviation 5.00
|
-5.6 score on a scale
Standard Deviation 5.46
|
-3.3 score on a scale
Standard Deviation 4.61
|
SECONDARY outcome
Timeframe: Change from baseline in the mean CGI-S score at Day 14Population: Intent to treat (ITT) population is considered for outcome measure.
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.
Outcome measures
| Measure |
SUVN-G3031 2mg
n=54 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=52 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=55 Participants
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Clinical Global Impression of Severity
|
-1.2 score on a scale
Standard Deviation 1.24
|
-1.4 score on a scale
Standard Deviation 1.19
|
-0.8 score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Change from baseline in the mean MWT score at Day 14Population: Intent to treat (ITT) population is considered for outcome measure.
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.
Outcome measures
| Measure |
SUVN-G3031 2mg
n=54 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=52 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=57 Participants
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Maintenance of Wakefulness Test
|
2.07 minutes
Standard Deviation 4.68
|
4.25 minutes
Standard Deviation 6.52
|
2.73 minutes
Standard Deviation 7.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Analysis of Patient Global Impression of Change (PGI-C) at Day 14Population: Intent to treat (ITT) population is considered for outcome measure.
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.
Outcome measures
| Measure |
SUVN-G3031 2mg
n=53 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=51 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=54 Participants
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Patient Global Impression of Change
|
3.2 score on a scale
Standard Deviation 1.16
|
2.8 score on a scale
Standard Deviation 1.10
|
3.7 score on a scale
Standard Deviation 1.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Analysis of Clinical Global Impression of Change (CGI-C) at Day 14Population: Intent to treat (ITT) population is considered for outcome measure.
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.
Outcome measures
| Measure |
SUVN-G3031 2mg
n=54 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=53 Participants
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=57 Participants
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Clinical Global Impression of Change
|
2.8 score on a scale
Standard Deviation 1.01
|
2.6 score on a scale
Standard Deviation 0.92
|
3.5 score on a scale
Standard Deviation 0.91
|
Adverse Events
SUVN-G3031 2mg
SUVN-G3031 4mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SUVN-G3031 2mg
n=63 participants at risk
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
SUVN-G3031 4mg
n=63 participants at risk
Orally taken once daily for 14 days
SUVN-G3031: SUVN-G3031 Tablets
|
Placebo
n=62 participants at risk
Orally taken once daily for 14 days
Placebo: Placebo Tablets
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
9.5%
6/63 • Number of events 7 • From screening to Day 21
|
17.5%
11/63 • Number of events 11 • From screening to Day 21
|
3.2%
2/62 • Number of events 2 • From screening to Day 21
|
|
Psychiatric disorders
Abnormal dreams
|
4.8%
3/63 • Number of events 3 • From screening to Day 21
|
7.9%
5/63 • Number of events 6 • From screening to Day 21
|
0.00%
0/62 • From screening to Day 21
|
|
Gastrointestinal disorders
Nausea
|
7.9%
5/63 • Number of events 6 • From screening to Day 21
|
17.5%
11/63 • Number of events 13 • From screening to Day 21
|
3.2%
2/62 • Number of events 2 • From screening to Day 21
|
|
Vascular disorders
Hot flush
|
4.8%
3/63 • Number of events 3 • From screening to Day 21
|
11.1%
7/63 • Number of events 7 • From screening to Day 21
|
1.6%
1/62 • Number of events 1 • From screening to Day 21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60