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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 37.5 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| 75 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| 150 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| 300 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| Placebo | Active Comparator | Once Daily Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP-110 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | United States | ||
| Mayo Clinic in Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34283019 | Derived | 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. | |
| 33631141 |
Not provided
Not provided
During screening, subjects completed a medical exam. An overnight Polysomnography (PSG) assessment followed by MWT and 24-hour ABPM were conducted at baseline. After successful completion of the screening and baseline visits subjects were randomized in a 1:1:2:2:2 ratio to receive 37.5, 75, 150, or 300 mg JZP- 110 or placebo.
Note: 476 subjects were enrolled and randomized, however 2 subjects never received drug. This resulted in 474 subjects comprising the safety population.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 37.5 mg of JZP-110 | 37.5 mg JZP-110 administered orally, once daily (QD), for the 12-week treatment phase. |
| FG001 | 75 mg of JZP-110 | 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. |
| 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 | Feb 8, 2016 | Apr 19, 2019 |
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| Placebo oral tablet |
| Drug |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Weeks 1, 4, and 8 |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| UC San Diego Medical Center | La Jolla | California | 92037 | United States |
| So Cal Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | United States |
| Pacific Sleep Medicine | Oceanside | California | 92054 | United States |
| Stanford University Center for Narcolepsy | Redwood City | California | 94063 | United States |
| Pacific Research Network, Inc. | San Diego | California | 92103 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | United States |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | United States |
| SleepMed of Central Georgia | Macon | Georgia | 31201 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Illinois at Chicago College of Nursing | Chicago | Illinois | 60612 | United States |
| Kentucky Research Group | Louisville | Kentucky | 40218 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Neurocare, Inc. | Newton | Massachusetts | 24590 | United States |
| Henry Ford Hospital Sleep Disorders & Research Center | Detroit | Michigan | 48202 | United States |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | United States |
| Minnesota Lung Center | Edina | Minnesota | 55435 | United States |
| Sleep Medicine & Research Center, St. Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| University of Missouri | Columbia | Missouri | 65201 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| Clinilabs | New York | New York | 10019 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Hickory Research Center | Hickory | North Carolina | 28602 | United States |
| Hickory Research Center, ARSM Research, LLC | Huntersville | North Carolina | 28078 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Northcoast Clinical Trials Inc. | Beachwood | Ohio | 44122 | United States |
| Sleep Management Institute | Cincinnati | Ohio | 45245 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45255 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Southwest Cleveland Sleep Research Center | Cleveland | Ohio | 44130 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio Sleep Medicine & Neuroscience Institute | Dublin | Ohio | 43017 | United States |
| Mercy St. Anne & Mercy St. Charles Sleep Disorders Center | Toledo | Ohio | 43606 | United States |
| Sleep Med of South Carolina | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials of Neurology LP | Austin | Texas | 78731 | United States |
| Todd J. Swick | Houston | Texas | 77063 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Niagra Clinical Research | Niagra Falls | Ontario | L2E 7H9 | Canada |
| Toronto Sleep Institute | Toronto | Ontario | M4P 1P2 | Canada |
| Toronto Psychiatric Research Foundation | Toronto | Ontario | M5K 2A7 | Canada |
| Pediatric Sleep Research Inc. | Toronto | Ontario | M6J 3S3 | Canada |
| Hospital Roger Salengro | Lille | 59000 | France |
| Universite Paris 5 Hôtel-Dieu | Paris | 75004 | France |
| Hopital Bichat - Claude Bernard | Paris | 75018 | France |
| medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum | Regensburg | Bavaria | 93053 | Germany |
| Universitätsklinikum Münster Department für Neurologie | Münster | North Rhine-Westphalia | 48149 | Germany |
| Advanced Sleep Research GmbH | Berlin | 10117 | Germany |
| Studienzentrum Wilhelmshoehe | Kassel | 34131 | Germany |
| Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH | Schwerin | 19053 | Germany |
| Sleep Wake Center SEIN Heemstede | Heemsteded | North Holland | 2103 SW | Netherlands |
| Derived |
| 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. |
| 33394323 | Derived | 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. |
| 33226332 | Derived | 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. |
| 32353246 | Derived | 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. |
| 30521757 | Derived | 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. |
| FG002 | 150 mg of JZP-110 | Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD. |
| FG003 | 300 mg of JZP-110 | Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| FG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 37.5 mg of JZP-110 | 37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase. |
| BG001 | 75 mg of JZP-110 | 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. |
| BG002 | 150 mg of JZP-110 | Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD. |
| BG003 | 300 mg of JZP-110 | Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| BG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
| BG005 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | 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. | Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Least Squares Mean | Standard Error | points on a scale | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Number | percentage of subjects | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | points on a scale | Baseline to Weeks 1, 4, and 8 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Number | percentage of subjects | Weeks 1, 4, and 8 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Number | percentage of subjects | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects. | Posted | Number | percentage of subjects | Weeks 1, 4, and 8 |
|
Through Week 14
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 37.5 mg of JZP-110 | 37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase. | 0 | 58 | 2 | 58 | 17 | 58 |
| EG001 | 75 mg of JZP-110 | 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. | 0 | 62 | 0 | 62 | 21 | 62 |
| EG002 | 150 mg of JZP-110 | Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD. | 0 | 117 | 1 | 117 | 41 | 117 |
| EG003 | 300 mg of JZP-110 | Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. | 0 | 118 | 0 | 118 | 60 | 118 |
| EG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. | 0 | 119 | 2 | 110 | 30 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Streptococcal endocarditis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
|
The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Disclosure & Transparency | Jazz Pharmaceuticals | 2158709177 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2017 | Apr 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000623308 | solriamfetol |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | 300 mg of JZP-110 | Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
| OG003 | 300 mg of JZP-110 | Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD. |
| OG004 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
|
|