Trial · NCT07540364
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
NCT07540364, Phase 3, Recruiting, Suven Life Sciences Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE). Trials, record NCT07540364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07540364
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
- NCT number
- NCT07540364
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Suven Life Sciences Limited
- Conditions
- Narcolepsy
- Interventions
- Samelisant, Placebo
- First posted
- 2026-04-20
- Last updated
- 2026-09-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12 | Baseline to Week 12 | The ESS is a subjective measure of daytime sleepiness. The participant rates on a 4-point Likert scale how likely it is that he/she would doze in 8 different situations. Scoring of the answers is 0 to 3, with 0 being "would never doze" and 3 being "high chance of dozing". The total ESS score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. A decrease from baseline in ESS score represents improvement. |
| Secondary | Change from Baseline for Maintenance of Wakefulness Test (MWT) score at Week 12 | Baseline to Week 12 | 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. |
| Secondary | Change from Baseline in the Clinical Global Impression of Severity of Illness (CGI-S) score as related to excessive daytime sleepiness (EDS) at Week 12 | Baseline to Week 12 | The CGI-S will be used to rate the severity of each participant's illness related to depressive narcolepsy or EDS symptoms on a 7-point scale, which includes the following gradations: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill. |
| Secondary | Change from Baseline in Weekly Cataplexy Rate (WCR) for Narcolepsy Type 1 (NT1) at Week 12 | Baseline to Week 12 | The WCR is a measure designed to evaluate the average weekly cataplexy frequency in participants who experience cataplexy. Participants who experience cataplexy will complete a daily diary to record the number of cataplexy attacks that occur each day beginning after discontinuation of narcolepsy medication and throughout the 12-week treatment phase of the study. |
| Secondary | Change from Baseline in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) score for Narcolepsy Type 1 (NT1) at Week 12 | Baseline to Week 12 | NSS-CT is a 15-item self-administered scale that requires participants to evaluate themselves with respect to symptoms and quantitative aspects of cataplexy/sleep attacks; impact on social, family, and work life, hallucinations; and sleep paralysis. Each item requires participants to choose among 4 or 6 options. Scores range from 0 to 57 points with the following breakdown: 0 to 14 (mild), 15 to 28 (moderate), 29 to 42 (severe), 43 to 57 (very severe), where degree of severity describes the impact of the narcolepsy on the participant's life. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT07540364
GET https://conductscience.org/api/trials/v1/NCT07540364/registered