NarcolepsyPhase 3NCT07540364
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
A Phase 3 study testing Samelisant in people with Narcolepsy, run by Suven Life Sciences Limited at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Samelisant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 19 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index ranging from 18 to 45 kg/m2 (both inclusive).
- Narcolepsy with or without cataplexy (Narcolepsy Type 1 [NT1] or Narcolepsy Type 2 [NT2]) based on the International Classification of Sleep Disorders 3-TR/ Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for the diagnosis of narcolepsy.
- For NT1 only, current continuing presence of cataplexy as defined by participant report for the last 3 months and have average of ≥4 weekly cataplexy events during the last 2 weeks of the washout period.
- At the screening Visit and the Baseline Visit, participants who are not on treatment for EDS must have ESS scores ≥12 (as assessed with a look-back period of 1 week).
- A mean MWT time of <12 minutes across the first 4 sessions at Baseline.
- Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form.
- Able to show compliance with sleep diary entries for at least 5 times/week in the final 2 weeks of the screening Period (non-compliant participants will not be included).
Who cannot join
- Median habitual wake-up time after 9 am as assessed by sleep diary, habitual sleep time of <6 h and median habitual bedtime past 1 am, as determined by sleep diary entries.
- Use of any investigational therapy within the 30-day period (or 5 half-lives, whichever is longer) prior to enrollment.
- History of (within past 3 months) or current substance use disorder involving illicit drugs, alcohol, or marijuana, as per DSM-5-TR criteria. Alcohol and/or recreational drugs use within 24 hours of study visits is strictly prohibited.
- Excessive caffeine (defined as >600 mg/day) use at least 1 week prior to Baseline assessments and during the study.
- Nicotine dependence that affects sleep (eg, a participant who routinely awakens at night to smoke).
- If receiving stimulants, modafinil, oxybates, pitolisant, solriamfetol, bupropion or other treatments for narcolepsy, and unwilling or unable to complete weaning 2 weeks prior to Baseline visit (Day 1)
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- Clinically significant ECG abnormalities. Participants are excluded with a screening ECG Fridericia's correction of QT (QTcF) interval ≥450 msec for men and ≥470 msec for women obtained after 5-minute rest in a supine position using a digital ECG.
- Concurrent use of hypnotics, tranquilizers, centrally acting H1 receptor antagonists, benzodiazepines, anticonvulsants, or clonidine, tricyclic antidepressants that have H1-antihistamine properties (clomipramine, protriptyline).
- Adjunctive pharmacotherapy directed against cataplexy (including but not limited to venlafaxine, fluoxetine, and gamma hydroxybutyrate) is prohibited.
- An occupation requiring variable shift work, variable wake times, night shifts, frequent overnight travel or expected overnight travel across > 3 time zones during the study which disrupts sleep patterns and working remotely leading to inconsistent sleep duration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bogan Sleep Consultants
Columbia, South Carolina, 29201
About this study
Official title: A Phase 3, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Samelisant Compared to Placebo in Patients With Narcolepsy With or Without Cataplexy
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.
Read the detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of Samelisant compared to placebo in the treatment of excessive daytime sleepiness in male or female participants ≥18 years of age with narcolepsy with and without cataplexy.
Participants will be randomized to receive either Samelisant or matching placebo tablets for duration of 12 weeks. Treatment allocation will remain blinded to both participants and investigators throughout the study, except in cases of medical necessity.
- Conditions
- Narcolepsy
- Being tested
- Samelisant, Placebo
- Keywords
- Samelisant, SUVN-G3031, Excessive Daytime Sleepiness, Narcolepsy, Cataplexy
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence, Cataplexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamelisantDrug
Also called SUVN-G3031
Tablet dosage form, once a day
PlaceboDrug
Matching placebo tablets, once a day
| Study group | Role | What they receive |
|---|---|---|
| Samelisant Tablets | Active comparator | Not described Receives: Drug: Samelisant |
| Placebo Tablets | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in total Epworth Sleepiness Scale (ESS) score at 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.
Measured: Baseline to Week 12
Secondary outcomes (4)
Change from Baseline for Maintenance of Wakefulness Test (MWT) score at 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.
Measured: Baseline to Week 12
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
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.
Measured: Baseline to Week 12
Change from Baseline in Weekly Cataplexy Rate (WCR) for Narcolepsy Type 1 (NT1) at 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.
Measured: Baseline to Week 12
Change from Baseline in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) score for Narcolepsy Type 1 (NT1) at 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startSep 2026 (estimated)
- Primary completion19 Nov 2027 (estimated)
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540364
- Sponsor's protocol ID
- CTP3S13031H3
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Samelisant Compared to Placebo in Patients With Narcolepsy With or Without Cataplexy
- ClinicalTrials.gov ID
- NCT07540364
- Acronym / sponsor ID
- CTP3S13031H3
- Conditions
- Narcolepsy
- Keywords
- Samelisant, SUVN-G3031, Excessive Daytime Sleepiness, Narcolepsy, Cataplexy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 19 Nov 2027 (estimated)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.
Detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of Samelisant compared to placebo in the treatment of excessive daytime sleepiness in male or female participants ≥18 years of age with narcolepsy with and without cataplexy.
Participants will be randomized to receive either Samelisant or matching placebo tablets for duration of 12 weeks. Treatment allocation will remain blinded to both participants and investigators throughout the study, except in cases of medical necessity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Samelisant Tablets | Active comparator | Drug: Samelisant |
| Placebo Tablets | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index ranging from 18 to 45 kg/m2 (both inclusive).
- Narcolepsy with or without cataplexy (Narcolepsy Type 1 [NT1] or Narcolepsy Type 2 [NT2]) based on the International Classification of Sleep Disorders 3-TR/ Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for the diagnosis of narcolepsy.
- For NT1 only, current continuing presence of cataplexy as defined by participant report for the last 3 months and have average of ≥4 weekly cataplexy events during the last 2 weeks of the washout period.
- At the screening Visit and the Baseline Visit, participants who are not on treatment for EDS must have ESS scores ≥12 (as assessed with a look-back period of 1 week).
- A mean MWT time of <12 minutes across the first 4 sessions at Baseline.
Key exclusion criteria (10 listed)
- Median habitual wake-up time after 9 am as assessed by sleep diary, habitual sleep time of <6 h and median habitual bedtime past 1 am, as determined by sleep diary entries.
- Use of any investigational therapy within the 30-day period (or 5 half-lives, whichever is longer) prior to enrollment.
- History of (within past 3 months) or current substance use disorder involving illicit drugs, alcohol, or marijuana, as per DSM-5-TR criteria. Alcohol and/or recreational drugs use within 24 hours of study visits is strictly prohibited.
- Excessive caffeine (defined as >600 mg/day) use at least 1 week prior to Baseline assessments and during the study.
- Nicotine dependence that affects sleep (eg, a participant who routinely awakens at night to smoke).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamelisantAlso: SUVN-G3031Tablet dosage form, once a day | Drug | Samelisant Tablets |
| PlaceboMatching placebo tablets, once a day | Drug | Placebo Tablets |
Primary outcome
Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12
Time frame: 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.
4 secondary outcomes
Change from Baseline for Maintenance of Wakefulness Test (MWT) score at Week 12
Time frame: Baseline to Week 12
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
Time frame: Baseline to Week 12
Change from Baseline in Weekly Cataplexy Rate (WCR) for Narcolepsy Type 1 (NT1) at Week 12
Time frame: Baseline to Week 12
Change from Baseline in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) score for Narcolepsy Type 1 (NT1) at Week 12
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Samelisant in people with Narcolepsy, run by Suven Life Sciences Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (+9140 2319 3956, narcolepsy@suven.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.