Obstructive Sleep ApneaPhase 3OSANCT02348606

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

A Phase 3 study testing JZP-110 in people with Obstructive Sleep Apnea, run by Jazz Pharmaceuticals at 59 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: JZP-110
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 476 participants
Where: 59 sitesin 5 countries
Study dates: May 2015to Dec 2016
Phase: Phase 3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

59 sites in 5 countries.

Country

City, postcode or hospital

59 sites in 5 countries

United States45 sites

NeuroTrials Research Inc.
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology LP
Austin, Texas, 78731
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Northcoast Clinical Trials Inc.
Beachwood, Ohio, 44122
PAB Clinical Research
Brandon, Florida, 33511
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, 63017
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
University of Illinois at Chicago College of Nursing
Chicago, Illinois, 60612
Sleep Management Institute
Cincinnati, Ohio, 45245
CTI Clinical Research Center
Cincinnati, Ohio, 45255
Case Western Reserve University
Cleveland, Ohio, 44106
Southwest Cleveland Sleep Research Center
Cleveland, Ohio, 44130
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri
Columbia, Missouri, 65201
Sleep Med of South Carolina
Columbia, South Carolina, 29201
Henry Ford Hospital Sleep Disorders & Research Center
Detroit, Michigan, 48202
Ohio Sleep Medicine & Neuroscience Institute
Dublin, Ohio, 43017
Duke University Medical Center
Durham, North Carolina, 27705
Minnesota Lung Center
Edina, Minnesota, 55435
Pulmonary Associates
Glendale, Arizona, 85306
MD Clinical
Hallandale, Florida, 33009
Hickory Research Center
Hickory, North Carolina, 28602
Todd J. Swick
Houston, Texas, 77063
Hickory Research Center, ARSM Research, LLC
Huntersville, North Carolina, 28078
UC San Diego Medical Center
La Jolla, California, 92037
Preferred Research Partners
Little Rock, Arkansas, 72211
So Cal Institute For Respiratory Diseases, Inc.
Los Angeles, California, 90048
Kentucky Research Group
Louisville, Kentucky, 40218
SleepMed of Central Georgia
Macon, Georgia, 31201
Clinilabs
New York, New York, 10019
Neurocare, Inc.
Newton, Massachusetts, 24590
Pacific Sleep Medicine
Oceanside, California, 92054
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Stanford University Center for Narcolepsy
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Pacific Research Network, Inc.
San Diego, California, 92103
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Swedish Medical Center
Seattle, Washington, 98122
Clayton Sleep Institute
St Louis, Missouri, 63143
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707
Clinical Neurophysiology Services
Sterling Heights, Michigan, 48314
Montefiore Medical Center
The Bronx, New York, 10467
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
Toledo, Ohio, 43606
Florida Pediatric Research Institute
Winter Park, Florida, 32789

Other trials in United States

Canada5 sites

London Health Sciences Centre
London, Ontario, N6A 5W9
Niagra Clinical Research
Niagra Falls, Ontario, L2E 7H9
Toronto Sleep Institute
Toronto, Ontario, M4P 1P2
Toronto Psychiatric Research Foundation
Toronto, Ontario, M5K 2A7
Pediatric Sleep Research Inc.
Toronto, Ontario, M6J 3S3

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Germany5 sites

Advanced Sleep Research GmbH
Berlin, 10117
Studienzentrum Wilhelmshoehe
Kassel, 34131
Universitätsklinikum Münster Department für Neurologie
Münster, North Rhine-Westphalia, 48149
medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
Regensburg, Bavaria, 93053
Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, 19053

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France3 sites

Hospital Roger Salengro
Lille, 59000
Universite Paris 5 Hôtel-Dieu
Paris, 75004
Hopital Bichat - Claude Bernard
Paris, 75018

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Netherlands1 site

Sleep Wake Center SEIN Heemstede
Heemsteded, North Holland, 2103 SW

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About this study

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)

Conditions: Obstructive Sleep Apnea
Being tested: JZP-110, Placebo oral tablet
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JZP-110Drug
Placebo oral tabletDrug

Study groups in NCT02348606
Study group	Role	What they receive
37.5 mg of JZP-110	Active comparator	Once Daily Dosing Receives: Drug: JZP-110
75 mg of JZP-110	Active comparator	Once Daily Dosing Receives: Drug: JZP-110
150 mg of JZP-110	Active comparator	Once Daily Dosing Receives: Drug: JZP-110
300 mg of JZP-110	Active comparator	Once Daily Dosing Receives: Drug: JZP-110
Placebo	Active comparator	Once Daily Dosing Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline to Week 12

Secondary outcomes (7)

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.
Measured: 12 Weeks
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.
Measured: Baseline and 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.
Measured: 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.
Measured: Baseline to Weeks 1, 4, and 8
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.
Measured: Weeks 1, 4, and 8
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.
Measured: Week 12
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.
Measured: Weeks 1, 4, and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Dec 2016

First posted28 Jan 2015 (estimated)
Study startMay 2015
Primary completionDec 2016
Study completionDec 2016

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 (6)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 476 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02348606
Sponsor's protocol ID: 14-003
Acronym: OSA
Status last verified: Jul 2019
First submitted: 15 Jan 2015
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 34283019
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.
PubMed 33631141
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.
PubMed 33394323
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.
PubMed 33226332
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.
PubMed 32353246
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.
PubMed 30521757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
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Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
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All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02348606
Acronym / sponsor ID: OSA / 14-003
Conditions: Obstructive Sleep Apnea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 476 participants (actual)
Lead sponsor: Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 23 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
37.5 mg of JZP-110	Active comparator	Drug: JZP-110Once Daily Dosing
75 mg of JZP-110	Active comparator	Drug: JZP-110Once Daily Dosing
150 mg of JZP-110	Active comparator	Drug: JZP-110Once Daily Dosing
300 mg of JZP-110	Active comparator	Drug: JZP-110Once Daily Dosing
Placebo	Active comparator	Drug: Placebo oral tabletOnce Daily Dosing

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
JZP-110	Drug	150 mg of JZP-110, 300 mg of JZP-110, 37.5 mg of JZP-110, 75 mg of JZP-110
Placebo oral tablet	Drug	Placebo

Primary outcome

Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Time frame: 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
Time frame: 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.

7 secondary outcomes

Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Time frame: 12 Weeks
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
Time frame: Baseline and 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
Time frame: Baseline to Week 4
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
Time frame: Baseline to Weeks 1, 4, and 8
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
Time frame: Weeks 1, 4, and 8
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
Time frame: Week 12
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
Time frame: Weeks 1, 4, and 8

Results and safety

Results posted to the registry on 23 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
37.5 mg of JZP-110	58	49
75 mg of JZP-110	62	54
150 mg of JZP-110	117	106
300 mg of JZP-110	118	94
Placebo	119	101

Primary outcome: Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: minutes

Measure	37.5 mg of JZP-110 n = 56	75 mg of JZP-110 n = 58	150 mg of JZP-110 n = 116	300 mg of JZP-110 n = 115	Placebo n = 114
Value	4.74 (1.418)	9.08 (1.358)	10.96 (0.973)	12.99 (1.038)	0.21 (0.997)

Population analysed: Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects.

Primary outcome: Change in ESS Score From Baseline to Week 12

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: points on a scale

Measure	37.5 mg of JZP-110 n = 56	75 mg of JZP-110 n = 58	150 mg of JZP-110 n = 116	300 mg of JZP-110 n = 115	Placebo n = 114
Value	-5.1 (0.64)	-5.0 (0.62)	-7.7 (0.44)	-7.9 (0.46)	-3.3 (0.45)

Population analysed: Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through Week 14. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
37.5 mg of JZP-110	2 of 58 (3.4%)	17 of 58 (29.3%)	0 of 58
75 mg of JZP-110	0 of 62 (0%)	21 of 62 (33.9%)	0 of 62
150 mg of JZP-110	1 of 117 (0.9%)	41 of 117 (35%)	0 of 117
300 mg of JZP-110	0 of 118 (0%)	60 of 118 (50.8%)	0 of 118
Placebo	2 of 110 (1.8%)	30 of 119 (25.2%)	0 of 119

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34283019Rosenberg 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.
Derived from this study: PubMed 33631141Schweitzer 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.
Derived from this study: PubMed 33394323Weaver 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.
Derived from this study: PubMed 33226332Rosenberg 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.
Derived from this study: PubMed 32353246Weaver 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.
Derived from this study: PubMed 30521757Schweitzer 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.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

59 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JZP-110 in people with Obstructive Sleep Apnea, run by Jazz Pharmaceuticals at 59 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada, Germany, France, Netherlands. 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. 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?

Yes. Results are posted in the registry (first posted 23 Jul 2019). 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?

Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. 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 NCT02348606, which also lists 6 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 23 Jul 2019.