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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUVN-G3031 2mg | Experimental | Orally taken once daily for 14 days |
|
| SUVN-G3031 4mg | Experimental | Orally taken once daily for 14 days |
|
| Placebo | Placebo Comparator | Orally taken once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVN-G3031 | Drug | SUVN-G3031 Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline in the mean total ESS score at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline in the mean CGI-S score at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center o f Alabama | Birmingham | Alabama | 35213 | United States | ||
| Santa Monica Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39504585 | Result | 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. | |
| 32399853 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SUVN-G3031 2mg | Orally taken once daily for 14 days SUVN-G3031: SUVN-G3031 Tablets |
| FG001 | SUVN-G3031 4mg | Orally taken once daily for 14 days SUVN-G3031: SUVN-G3031 Tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2023 | Dec 7, 2024 |
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| Placebo | Drug | Placebo Tablets |
|
| 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. |
| Change from baseline in the mean MWT score at Day 14 |
| Analysis of Patient Global Impression of Change (PGI-C) at Day 14 |
| Clinical Global Impression of Change | 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. | Analysis of Clinical Global Impression of Change (CGI-C) at Day 14 |
| Los Angeles |
| California |
| 90025 |
| United States |
| Southern California Institute for Respiratory Diseases, Inc. | Los Angeles | California | 90048-6138 | United States |
| Pacific Research Network, Inc. | San Diego | California | 92103 | United States |
| SDS Clinical Trials Inc. | Santa Ana | California | 92705 | United States |
| Meris Clinical Research | Brandon | Florida | 33511 | United States |
| Teradan Clinical Trials | Brandon | Florida | 33511 | United States |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | United States |
| PDS Research | Kissimmee | Florida | 34741 | United States |
| Sleep Medicine Specialists of South Florida, PA | Miami | Florida | 33126 | United States |
| Ivetmar Medical Group, LLC | Miami | Florida | 33155 | United States |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | United States |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| NeuroTrials Research Inc | Atlanta | Georgia | 30342 | United States |
| The Neuro Center | Gainesville | Georgia | 30501 | United States |
| IACT Health | Lawrenceville | Georgia | 30045 | United States |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | United States |
| IACT Health | Rincon | Georgia | 31326 | United States |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | United States |
| Helene A. Emsellem, MD PC | Chevy Chase | Maryland | 20815 | United States |
| Bronson Sleep Health | Portage | Michigan | 49024 | United States |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | United States |
| St Lukes Hospital, Sleep Medicine & Research Center | Chesterfield | Missouri | 63017 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | United States |
| Research Carolina Elite | Denver | North Carolina | 28078 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| Ohio Sleep Medicine Institute | Canton | Ohio | 44718 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | United States |
| Cleveland Clinic, Sleep Disorders Center | Cleveland | Ohio | 44195 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Bogan Sleep Consultants | Columbia | South Carolina | 29201 | United States |
| Lowcountry Lung Critical Care | North Charleston | South Carolina | 29406 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| Roadrunner Research | San Antonio | Texas | 78249 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | United States |
| Medical Arts Health Research Group | Kelowna | British Columbia | V1Y 4N7 | Canada |
| Jodha Tishon Inc | Toronto | Ontario | M5S 3A3 | Canada |
| Derived |
| Nirogi 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. |
| FG002 | Placebo | Orally taken once daily for 14 days Placebo: Placebo Tablets |
| Safety Population |
|
| Intent-to-treat (ITT) Population |
|
| COMPLETED |
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| NOT COMPLETED |
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A total of 188 (98.9%) patients who were randomized to specific treatment sequence were included in the safety population and this population is considered for baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | SUVN-G3031 2mg | Orally taken once daily for 14 days SUVN-G3031: SUVN-G3031 Tablets |
| BG001 | SUVN-G3031 4mg | Orally taken once daily for 14 days SUVN-G3031: SUVN-G3031 Tablets |
| BG002 | Placebo | Orally taken once daily for 14 days Placebo: Placebo Tablets |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Epworth Sleepiness Scale (ESS) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Clinical Global Impression of Severity (CGI-S) | Mean | Standard Deviation | units on a scale |
| |||||||||||||||
| Maintenance of Wakefulness Test (MWT) | Mean | Standard Deviation | minutes |
| |||||||||||||||
| Patient Global Impression of Change (PGI-C) | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat (ITT) population is considered for outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline in the mean total ESS score at Day 14 |
|
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| Secondary | 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. | Intent to treat (ITT) population is considered for outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline in the mean CGI-S score at Day 14 |
|
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| Secondary | 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. | Intent to treat (ITT) population is considered for outcome measure. | Posted | Mean | Standard Deviation | minutes | Change from baseline in the mean MWT score at Day 14 |
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| Other Pre-specified | Patient Global Impression of Change | 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. | Intent to treat (ITT) population is considered for outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Analysis of Patient Global Impression of Change (PGI-C) at Day 14 |
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| Other Pre-specified | Clinical Global Impression of Change | 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. | Intent to treat (ITT) population is considered for outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Analysis of Clinical Global Impression of Change (CGI-C) at Day 14 |
|
From screening to Day 21
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SUVN-G3031 2mg | Orally taken once daily for 14 days SUVN-G3031: SUVN-G3031 Tablets | 0 | 63 | 0 | 63 | 17 | 63 |
| EG001 | SUVN-G3031 4mg | Orally taken once daily for 14 days SUVN-G3031: SUVN-G3031 Tablets | 0 | 63 | 0 | 63 | 34 | 63 |
| EG002 | Placebo | Orally taken once daily for 14 days Placebo: Placebo Tablets | 0 | 62 | 0 | 62 | 5 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramakrishna Nirogi, PhD | Suven Life Sciences | +9140 2319 3956 | nvsrk@suven.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2023 | Dec 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D002385 | Cataplexy |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705512 | samelisant |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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