Clinical trial NCT02348606: "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Major Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive
2. Diagnosis of OSA according to ICSD-3 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
4. 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.
5. History of bariatric surgery within the past year or a history of any gastric bypass procedure
6. Presence or history of significant cardiovascular disease
7. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
8. Received an investigational drug in the past 30 days or five half-lives
9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
10. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Primary outcomes:
measure: Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in ESS Score From Baseline to Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
timeFrame: 12 Weeks
measure: Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12
timeFrame: Baseline and Week 12
measure: Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in ESS Score From Baseline to Week 1, Week 4, and Week 8
timeFrame: Baseline to Weeks 1, 4, and 8
measure: Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8
timeFrame: Weeks 1, 4, and 8
measure: Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8
timeFrame: Weeks 1, 4, and 8
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pulmonary Associates
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: La Jolla
country: United States
facility: UC San Diego Medical Center
state: California
city: Los Angeles
country: United States
facility: So Cal Institute For Respiratory Diseases, Inc.
state: California
city: Oceanside
country: United States
facility: Pacific Sleep Medicine
state: California
city: Redwood City
country: United States
facility: Stanford University Center for Narcolepsy
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc.
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Winter Park
country: United States
facility: Florida Pediatric Research Institute
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc.
state: Georgia
city: Macon
country: United States
facility: SleepMed of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago College of Nursing
state: Illinois
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Chevy Chase
country: United States
facility: The Center for Sleep & Wake Disorders
state: Maryland
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital Sleep Disorders & Research Center
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services
state: Michigan
city: Edina
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Chesterfield
country: United States
facility: Sleep Medicine & Research Center, St. Luke's Hospital
state: Missouri
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Clinilabs
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Hickory
country: United States
facility: Hickory Research Center
state: North Carolina
city: Huntersville
country: United States
facility: Hickory Research Center, ARSM Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Beachwood
country: United States
facility: Northcoast Clinical Trials Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Sleep Management Institute
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Southwest Cleveland Sleep Research Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine & Neuroscience Institute
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
state: Ohio
city: Columbia
country: United States
facility: Sleep Med of South Carolina
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology LP
state: Texas
city: Houston
country: United States
facility: Todd J. Swick
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Niagra Falls
country: Canada
facility: Niagra Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sleep Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Psychiatric Research Foundation
state: Ontario
city: Toronto
country: Canada
facility: Pediatric Sleep Research Inc.
state: Ontario
city: Lille
country: France
facility: Hospital Roger Salengro
city: Paris
country: France
facility: Universite Paris 5 Hôtel-Dieu
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Regensburg
country: Germany
facility: medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum
state: Bayern
city: Muenster
country: Germany
facility: Universitätsklinikum Münster Department für Neurologie
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: Advanced Sleep Research GmbH
city: Kassel
country: Germany
facility: Studienzentrum Wilhelmshoehe
city: Schwerin
country: Germany
facility: Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
city: Heemsteded
country: Netherlands
facility: Sleep Wake Center SEIN Heemstede
state: Noord Holland
Study officials:
References:
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.
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.
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.
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.
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.
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.