A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy (SUVN-G3031)
Primary Purpose
Narcolepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SUVN-G3031
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy focused on measuring SUVN-G3031, Narcolepsy with and without cataplexy, Cataplexy, Narcolepsy Type 1, Narcolepsy Type 2, Excessive Daytime Sleepiness (EDS), Histamine H3 receptor, Samelisant
Eligibility Criteria
Inclusion Criteria:
- 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 ESS score of ≥ 12; and mean 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Sleep Disorders Center o f Alabama
- Santa Monica Clinical Trials
- Southern California Institute for Respiratory Diseases, Inc.
- Pacific Research Network, Inc.
- SDS Clinical Trials Inc.
- Meris Clinical Research
- Teradan Clinical Trials
- St. Francis Medical Institute
- PDS Research
- Sleep Medicine Specialists of South Florida, PA
- Ivetmar Medical Group, LLC
- Florida Pediatric Research Institute
- Florida Pulmonary Research Institute, LLC
- NeuroTrials Research Inc
- The Neuro Center
- IACT Health
- Sleep Practitioners, LLC
- IACT Health
- Clinical Research Institute
- Helene A. Emsellem, MD PC
- Bronson Sleep Health
- Clinical Neurophysiology Services
- St Lukes Hospital, Sleep Medicine & Research Center
- Clayton Sleep Institute
- Research Carolina Elite
- Clinical Research of Gastonia
- Ohio Sleep Medicine Institute
- CTI Clinical Research Center
- Intrepid Research, LLC
- Cleveland Clinic, Sleep Disorders Center
- Ohio Sleep Medicine Institute
- Respiratory Specialists
- Medical University of South Carolina
- Bogan Sleep Consultants
- Lowcountry Lung Critical Care
- FutureSearch Trials of Neurology
- Sleep Therapy & Research Center
- Roadrunner Research
- Children's Hospital of the King's Daughters
- Medical Arts Health Research Group
- Jodha Tishon Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SUVN-G3031 2mg
SUVN-G3031 4mg
Placebo
Arm Description
Orally taken once daily for 14 days
Orally taken once daily for 14 days
Orally taken once daily for 14 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical Global Impression of Severity (CGI-S)
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.
Maintenance of Wakefulness Test (MWT)
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.
Full Information
NCT ID
NCT04072380
First Posted
August 26, 2019
Last Updated
October 19, 2023
Sponsor
Suven Life Sciences Limited
1. Study Identification
Unique Protocol Identification Number
NCT04072380
Brief Title
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Acronym
SUVN-G3031
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2019 (Actual)
Primary Completion Date
June 7, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suven Life Sciences Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
Keywords
SUVN-G3031, Narcolepsy with and without cataplexy, Cataplexy, Narcolepsy Type 1, Narcolepsy Type 2, Excessive Daytime Sleepiness (EDS), Histamine H3 receptor, Samelisant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SUVN-G3031 2mg
Arm Type
Experimental
Arm Description
Orally taken once daily for 14 days
Arm Title
SUVN-G3031 4mg
Arm Type
Experimental
Arm Description
Orally taken once daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally taken once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
SUVN-G3031
Other Intervention Name(s)
Samelisant
Intervention Description
SUVN-G3031 Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tablets
Primary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
Change from baseline in the mean total ESS score at Day 14
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Severity (CGI-S)
Description
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.
Time Frame
Change from baseline in the mean CGI-S score at Day 14
Title
Maintenance of Wakefulness Test (MWT)
Description
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.
Time Frame
Change from baseline in the mean MWT score at Day 14
Other Pre-specified Outcome Measures:
Title
Patient Global Impression of Change (PGI-C)
Description
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.
Time Frame
Proportion of subjects with improvement in the PGI-C score from baseline to Day 14
Title
Clinical Global Impression of Change (CGI-C)
Description
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.
Time Frame
Proportion of subjects reporting CGI-C scores of 1 or 2 or 3 at Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 ESS score of ≥ 12; and mean 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).
Exclusion Criteria:
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.
Facility Information:
Facility Name
Sleep Disorders Center o f Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Institute for Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-6138
Country
United States
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
SDS Clinical Trials Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Meris Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Teradan Clinical Trials
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
PDS Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Sleep Medicine Specialists of South Florida, PA
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Ivetmar Medical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Florida Pediatric Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The Neuro Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
IACT Health
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Sleep Practitioners, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
IACT Health
City
Rincon
State/Province
Georgia
ZIP/Postal Code
31326
Country
United States
Facility Name
Clinical Research Institute
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Helene A. Emsellem, MD PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Bronson Sleep Health
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Clinical Neurophysiology Services
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
St Lukes Hospital, Sleep Medicine & Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63123
Country
United States
Facility Name
Research Carolina Elite
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Intrepid Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Cleveland Clinic, Sleep Disorders Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Respiratory Specialists
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Bogan Sleep Consultants
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Lowcountry Lung Critical Care
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Roadrunner Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
Jodha Tishon Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3A3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32399853
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
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