Back to results"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA" (OSA)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
JZP-110
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Major Inclusion Criteria:
- Male or female between 18 and 75 years of age, inclusive
- Diagnosis of OSA according to ICSD-3 criteria
- Body mass index from 18 to <45 kg/m2
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Major Exclusion Criteria:
- Female subjects who are pregnant, nursing, or lactating
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
- History of bariatric surgery within the past year or a history of any gastric bypass procedure
- Presence or history of significant cardiovascular disease
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Received an investigational drug in the past 30 days or five half-lives
- Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Sites / Locations
- Pulmonary Associates
- Mayo Clinic in Arizona
- Preferred Research Partners
- UC San Diego Medical Center
- So Cal Institute For Respiratory Diseases, Inc.
- Pacific Sleep Medicine
- Stanford University Center for Narcolepsy
- Pacific Research Network, Inc.
- PAB Clinical Research
- MD Clinical
- Clinical Research Group of St. Petersburg
- Florida Pediatric Research Institute
- NeuroTrials Research Inc.
- SleepMed of Central Georgia
- Northwestern University Feinberg School of Medicine
- University of Illinois at Chicago College of Nursing
- Kentucky Research Group
- Johns Hopkins Hospital
- The Center for Sleep & Wake Disorders
- Neurocare, Inc.
- Henry Ford Hospital Sleep Disorders & Research Center
- Clinical Neurophysiology Services
- Minnesota Lung Center
- Sleep Medicine & Research Center, St. Luke's Hospital
- University of Missouri
- Clayton Sleep Institute
- Montefiore Medical Center
- Clinilabs
- Duke University Medical Center
- Hickory Research Center
- Hickory Research Center, ARSM Research, LLC
- Raleigh Neurology Associates
- Northcoast Clinical Trials Inc.
- Sleep Management Institute
- CTI Clinical Research Center
- Case Western Reserve University
- Southwest Cleveland Sleep Research Center
- Cleveland Clinic
- Ohio Sleep Medicine & Neuroscience Institute
- Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
- Sleep Med of South Carolina
- FutureSearch Trials of Neurology LP
- Todd J. Swick
- Sleep Therapy & Research Center
- Swedish Medical Center
- London Health Sciences Centre
- Niagra Clinical Research
- Toronto Sleep Institute
- Toronto Psychiatric Research Foundation
- Pediatric Sleep Research Inc.
- Hospital Roger Salengro
- Universite Paris 5 Hôtel-Dieu
- Hopital Bichat - Claude Bernard
- medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
- Universitätsklinikum Münster Department für Neurologie
- Advanced Sleep Research GmbH
- Studienzentrum Wilhelmshoehe
- Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
- Sleep Wake Center SEIN Heemstede
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
37.5 mg of JZP-110
75 mg of JZP-110
150 mg of JZP-110
300 mg of JZP-110
Placebo
Arm Description
Once Daily Dosing
Once Daily Dosing
Once Daily Dosing
Once Daily Dosing
Once Daily Dosing
Outcomes
Primary Outcome Measures
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Change in ESS Score From Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Secondary Outcome Measures
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
This is the key secondary endpoint.
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02348606
Brief Title
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Acronym
OSA
Official Title
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
476 (Actual)
8. Arms, Groups, and Interventions
Arm Title
37.5 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
75 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
150 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
300 mg of JZP-110
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Once Daily Dosing
Intervention Type
Drug
Intervention Name(s)
JZP-110
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Primary Outcome Measure Information:
Title
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Description
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Time Frame
Baseline to Week 12
Title
Change in ESS Score From Baseline to Week 12
Description
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Description
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
This is the key secondary endpoint.
Time Frame
12 Weeks
Title
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Description
Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Time Frame
Baseline and Week 12
Title
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4
Description
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
Time Frame
Baseline to Week 4
Title
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
Description
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Time Frame
Baseline to Weeks 1, 4, and 8
Title
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Description
Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
Time Frame
Weeks 1, 4, and 8
Title
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
Description
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Time Frame
Week 12
Title
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Description
Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Time Frame
Weeks 1, 4, and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria:
Male or female between 18 and 75 years of age, inclusive
Diagnosis of OSA according to ICSD-3 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent
Major Exclusion Criteria:
Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Received an investigational drug in the past 30 days or five half-lives
Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Facility Information:
Facility Name
Pulmonary Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
UC San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
So Cal Institute For Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Sleep Medicine
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
Stanford University Center for Narcolepsy
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Clinical Research Group of St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Florida Pediatric Research Institute
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
SleepMed of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago College of Nursing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
The Center for Sleep & Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
24590
Country
United States
Facility Name
Henry Ford Hospital Sleep Disorders & Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Clinical Neurophysiology Services
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Sleep Medicine & Research Center, St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Hickory Research Center
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Hickory Research Center, ARSM Research, LLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Northcoast Clinical Trials Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Sleep Management Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Southwest Cleveland Sleep Research Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Sleep Medicine & Neuroscience Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Sleep Med of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
FutureSearch Trials of Neurology LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Todd J. Swick
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Niagra Clinical Research
City
Niagra Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H9
Country
Canada
Facility Name
Toronto Sleep Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
Facility Name
Toronto Psychiatric Research Foundation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5K 2A7
Country
Canada
Facility Name
Pediatric Sleep Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 3S3
Country
Canada
Facility Name
Hospital Roger Salengro
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Universite Paris 5 Hôtel-Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitätsklinikum Münster Department für Neurologie
City
Muenster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Studienzentrum Wilhelmshoehe
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Sleep Wake Center SEIN Heemstede
City
Heemsteded
State/Province
Noord Holland
ZIP/Postal Code
2103 SW
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34283019
Citation
Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.
Results Reference
derived
PubMed Identifier
33631141
Citation
Schweitzer PK, Mayer G, Rosenberg R, Malhotra A, Zammit GK, Gotfried M, Chandler P, Baladi M, Strohl KP. Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. Chest. 2021 Jul;160(1):307-318. doi: 10.1016/j.chest.2021.02.033. Epub 2021 Feb 22.
Results Reference
derived
PubMed Identifier
33394323
Citation
Weaver TE, Menno DM, Bron M, Crosby RD, Morris S, Mathias SD. Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea. Sleep Breath. 2021 Sep;25(3):1707-1715. doi: 10.1007/s11325-020-02270-3. Epub 2021 Jan 4.
Results Reference
derived
PubMed Identifier
33226332
Citation
Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006. Erratum In: J Clin Sleep Med. 2021 Nov 1;17(11):2343.
Results Reference
derived
PubMed Identifier
32353246
Citation
Weaver TE, Drake CL, Benes H, Stern T, Maynard J, Thein SG, Andry JM Sr, Hudson JD, Chen D, Carter LP, Bron M, Lee L, Black J, Bogan RK. Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Aug;17(8):998-1007. doi: 10.1513/AnnalsATS.202002-136OC.
Results Reference
derived
PubMed Identifier
30521757
Citation
Schweitzer PK, Rosenberg R, Zammit GK, Gotfried M, Chen D, Carter LP, Wang H, Lu Y, Black J, Malhotra A, Strohl KP; TONES 3 Study Investigators. Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1421-1431. doi: 10.1164/rccm.201806-1100OC.
Results Reference
derived
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"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
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