NarcolepsyPhase 2SUVN-G3031NCT04072380
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
A Phase 2 study testing SUVN-G3031 in people with Narcolepsy, run by Suven Life Sciences Limited at 41 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- SUVN-G3031
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 21 Sep 2019to 13 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18 to 65 years (adult), inclusive.
- Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed).
- Have undergone a multiple sleep latency test (MSLT) study showing an MSLT of ≤ 8 minutes.
- An Epworth Sleepiness Scale (ESS) score of ≥ 12; and mean Maintenance of Wakefulness Test (MWT) time of < 12 min.
- Body mass index ranging from 18 to < 45 kg/m2
- Negative urine drug screen.
- A woman must be either not of childbearing potential or of childbearing potential practicing highly effective methods of birth control.
- Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form (ICF).
Who cannot join
- Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of < 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
- Use of any investigational therapy within the 30-day period prior to enrollment.
- Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial.
- Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke).
- Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate.
- Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any other cause of daytime sleepiness.
- Clinically significant ECG abnormalities.
- An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts sleep patterns.
Trial locations and contacts
41 sites in 2 countries.
41 sites in 2 countries
United States39 sites
NeuroTrials Research Inc
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology
Austin, Texas, 78731
Sleep Disorders Center o f Alabama
Birmingham, Alabama, 35213
Meris Clinical Research
Brandon, Florida, 33511
Teradan Clinical Trials
Brandon, Florida, 33511
Ohio Sleep Medicine Institute
Canton, Ohio, 44718
Medical University of South Carolina
Charleston, South Carolina, 29425
St Lukes Hospital, Sleep Medicine & Research Center
Chesterfield, Missouri, 63017
Helene A. Emsellem, MD PC
Chevy Chase, Maryland, 20815
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Intrepid Research, LLC
Cincinnati, Ohio, 45245
St. Francis Medical Institute
Clearwater, Florida, 33765
Cleveland Clinic, Sleep Disorders Center
Cleveland, Ohio, 44195
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Research Carolina Elite
Denver, North Carolina, 28078
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
The Neuro Center
Gainesville, Georgia, 30501
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
PDS Research
Kissimmee, Florida, 34741
IACT Health
Lawrenceville, Georgia, 30045
Santa Monica Clinical Trials
Los Angeles, California, 90025
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, 90048-6138
Sleep Practitioners, LLC
Macon, Georgia, 31210
Sleep Medicine Specialists of South Florida, PA
Miami, Florida, 33126
Ivetmar Medical Group, LLC
Miami, Florida, 33155
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Lowcountry Lung Critical Care
North Charleston, South Carolina, 29406
Bronson Sleep Health
Portage, Michigan, 49024
IACT Health
Rincon, Georgia, 31326
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Roadrunner Research
San Antonio, Texas, 78249
Pacific Research Network, Inc.
San Diego, California, 92103
SDS Clinical Trials Inc.
Santa Ana, California, 92705
Clayton Sleep Institute
St Louis, Missouri, 63123
Clinical Neurophysiology Services
Sterling Heights, Michigan, 48314
Clinical Research Institute
Stockbridge, Georgia, 30281
Florida Pediatric Research Institute
Winter Park, Florida, 32789
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
Canada2 sites
Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7
Jodha Tishon Inc
Toronto, Ontario, M5S 3A3
About this study
Official title: 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
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.
Read the detailed description
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.
- Conditions
- Narcolepsy
- Being tested
- SUVN-G3031, Placebo
- Keywords
- SUVN-G3031, Narcolepsy with and without cataplexy, Cataplexy, Narcolepsy Type 1, Narcolepsy Type 2, Excessive Daytime Sleepiness (EDS), Histamine H3 receptor, Samelisant
- Medical subject headings
- Narcolepsy, Cataplexy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVN-G3031Drug
Also called Samelisant
SUVN-G3031 Tablets
PlaceboDrug
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| SUVN-G3031 2mg | Experimental | Orally taken once daily for 14 days Receives: Drug: SUVN-G3031 |
| SUVN-G3031 4mg | Experimental | Orally taken once daily for 14 days Receives: Drug: SUVN-G3031 |
| Placebo | Placebo comparator | Orally taken once daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale
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.
Measured: Change from baseline in the mean total ESS score at Day 14
Secondary outcomes (2)
Clinical Global Impression of Severity
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.
Measured: Change from baseline in the mean CGI-S score at Day 14
Maintenance of Wakefulness Test
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.
Measured: Change from baseline in the mean MWT score at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start21 Sep 2019
- Primary completion7 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
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
- NCT04072380
- Sponsor's protocol ID
- CTP2S13031H3
- Acronym
- SUVN-G3031
- Status last verified
- Jan 2025
- First submitted
- 26 Aug 2019
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Nirogi R, Shinde A, Goyal VK, Ravula J, Benade V, Jetta S, Pandey SK, Subramanian R, Chowdary Palacharla VR, Mohammed AR, Abraham R, Dogiparti DK, Kalaikadhiban I, Jayarajan P, Jasti V, Bogan RK. Samelisant (SUVN-G3031), a histamine 3 receptor inverse agonist: Results from the phase 2 double-blind randomized placebo-controlled study for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Sleep Med. 2024 Dec;124:618-626. doi: 10.1016/j.sleep.2024.10.037. Epub 2024 Oct 30.
PubMed 39504585Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.
PubMed 32399853
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04072380
- Acronym / sponsor ID
- SUVN-G3031 / CTP2S13031H3
- Conditions
- Narcolepsy
- Keywords
- SUVN-G3031, Narcolepsy with and without cataplexy, Cataplexy, Narcolepsy Type 1, Narcolepsy Type 2, Excessive Daytime Sleepiness (EDS), Histamine H3 receptor, Samelisant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2019 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SUVN-G3031 2mg | Experimental | Drug: SUVN-G3031Orally taken once daily for 14 days |
| SUVN-G3031 4mg | Experimental | Drug: SUVN-G3031Orally taken once daily for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboOrally taken once daily for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages of 18 to 65 years (adult), inclusive.
- Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed).
- Have undergone a multiple sleep latency test (MSLT) study showing an MSLT of ≤ 8 minutes.
- An Epworth Sleepiness Scale (ESS) score of ≥ 12; and mean Maintenance of Wakefulness Test (MWT) time of < 12 min.
- Body mass index ranging from 18 to < 45 kg/m2
Key exclusion criteria (8 listed)
- Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of < 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
- Use of any investigational therapy within the 30-day period prior to enrollment.
- Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial.
- Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke).
- Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate.
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 |
|---|---|---|
| SUVN-G3031Also: SamelisantSUVN-G3031 Tablets | Drug | SUVN-G3031 2mg, SUVN-G3031 4mg |
| PlaceboPlacebo Tablets | Drug | Placebo |
Primary outcome
Epworth Sleepiness Scale
Time frame: 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.
2 secondary outcomes
Clinical Global Impression of Severity
Time frame: Change from baseline in the mean CGI-S score at Day 14
Maintenance of Wakefulness Test
Time frame: Change from baseline in the mean MWT score at Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39504585Nirogi R, Shinde A, Goyal VK, Ravula J, Benade V, Jetta S, Pandey SK, Subramanian R, Chowdary Palacharla VR, Mohammed AR, Abraham R, Dogiparti DK, Kalaikadhiban I, Jayarajan P, Jasti V, Bogan RK. Samelisant (SUVN-G3031), a histamine 3 receptor inverse agonist: Results from the phase 2 double-blind randomized placebo-controlled study for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Sleep Med. 2024 Dec;124:618-626. doi: 10.1016/j.sleep.2024.10.037. Epub 2024 Oct 30.
- Derived from this study: PubMed 32399853Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.
- Individual participant dataSharing planned: No
Related trials for Narcolepsy
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUVN-G3031 in people with Narcolepsy, run by Suven Life Sciences Limited at 41 sites in 2 countries.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale (time frame: Change from baseline in the mean total ESS score at Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072380, which also lists 2 linked publications.
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 13 Jan 2025.