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This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| 150 mg JZP-110 | Active Comparator | Once Daily Dosing |
|
| 300 mg of JZP-110 | Active Comparator | Once Daily Dosing |
|
| Placebo | Placebo Comparator | Once Daily Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP-110 | Drug |
| ||
| Placebo oral tablet |
| 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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing. | 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 treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse | Baseline to Week 12 |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Pulmonary Associates |
| 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. | |
| 33226332 |
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239 subjects were randomized in a 1:1:1:1 ratio to receive placebo, 75 mg JZP-110, 150 mg JZP-110 or 300 mg JZP-110. 236 subjects received at least 1 dose of study medication and comprised the Safety Population; the remaining 3 subjects were randomized in error (did not receive study medication) and were excluded from the Safety Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | 75 mg of JZP-110 | 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. |
| FG001 | 150 mg 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD. |
| 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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| Drug |
|
| Change in Sleep Latency Time on MWT Trial 1 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 from baseline for sleep latency in MWT during trial 1 at week 12 |
| Change in Sleep Latency Time on MWT Trial 2 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 from baseline for sleep latency in MWT during trial 2 at week 12 |
| Change in Sleep Latency Time on MWT Trial 3 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 from baseline for sleep latency in MWT during trial 3 at week 12 |
| Change in Sleep Latency Time on MWT Trial 4 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 from baseline for sleep latency in MWT during trial 4 at week 12 |
| Change in Sleep Latency Time on MWT Trial 5 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 from baseline for sleep latency in MWT during trial 5 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. | Baseline to Week 4 |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| So Cal Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | United States |
| Pacific Sleep Medicine | Oceanside | California | 92054 | United States |
| SDS Clinical Trials | Orange | California | 92868 | United States |
| Stanford University Center for Narcolepsy | Redwood City | California | 94063 | United States |
| Pacific Research Network, Inc. | San Diego | California | 92103 | United States |
| Critical Care Pulmonary & Sleep Associates, LLC | Lakewood | Colorado | 80228 | 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 |
| Emory Sleep Center | Atlanta | Georgia | 30329 | United States |
| NeuroTrials | 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 Chicago, College of Nursing | Chicago | Illinois | 60612 | United States |
| Veritas Clinical Specialties LTD | Topeka | Kansas | 66606 | United States |
| Kentucky Research Group | Louisville | Kentucky | 40218 | United States |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Neurocare, Inc. | Newton | Massachusetts | 24590 | United States |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | United States |
| Minnesota Lung Center | Edina | Minnesota | 55435 | United States |
| University of Missouri | Columbia | Missouri | 65201 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| New York University Medical center | New York | New York | 10016 | United States |
| Montefiore Medical center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | 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 |
| North Coast Clinical Trials Inc. | Beachwood | Ohio | 44122 | United States |
| Sleep Management Institute | Cincinnati | Ohio | 45245 | 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 |
| Lowcountry Lung Critical Care | Charleston | South Carolina | 29406 | 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 |
| 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 |
| CARSM Sleep Laboratory & Clinic | Montreal | Quebec | H4J 1C5 | Canada |
| Helsinki Sleep Clinic | Helsinki | 00420 | Finland |
| 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 |
| Universitaetsklinikum Muenster | 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 | Heemstede | North Holland | 2103 SW | Netherlands |
| 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. |
| 32588401 | Derived | Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2. |
| 31926465 | Derived | Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4. |
| FG002 | 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. |
| FG003 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 75 mg of JZP-110 | 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. |
| BG001 | 150 mg 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD. |
| BG002 | 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. |
| BG003 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. |
| BG004 | 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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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 treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Number | percentage of subjects | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Sleep Latency Time on MWT Trial 1 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Change from baseline for sleep latency in MWT during trial 1 at week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Sleep Latency Time on MWT Trial 2 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Change from baseline for sleep latency in MWT during trial 2 at week 12 |
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| Secondary | Change in Sleep Latency Time on MWT Trial 3 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Change from baseline for sleep latency in MWT during trial 3 at week 12 |
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| Secondary | Change in Sleep Latency Time on MWT Trial 4 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Change from baseline for sleep latency in MWT during trial 4 at week 12 |
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| Secondary | Change in Sleep Latency Time on MWT Trial 5 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Change from baseline for sleep latency in MWT during trial 5 at 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. | Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects. | Posted | Least Squares Mean | Standard Error | minutes | Baseline to Week 4 |
|
Through Week 14
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo administered orally, QD, for the 12 week treatment phase. | 0 | 59 | 0 | 59 | 17 | 59 |
| EG001 | 75 mg of JZP-110 | 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. | 0 | 59 | 0 | 59 | 19 | 59 |
| EG002 | 150 mg 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD. | 0 | 59 | 1 | 59 | 32 | 59 |
| 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 | 59 | 0 | 59 | 36 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | 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 | 215-970-7145 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2017 | Apr 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000623308 | solriamfetol |
Not provided
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Not provided
| Male |
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| 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. |
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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.
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