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

NCT02348606 | Completed Phase 3 Results

• 1 other identifier: 14-003
• Study Type: interventional
• Target: 476
• Locations: 5 countries
• Sites: 59

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12

  12 Weeks

• Change in Sleep Latency Time 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

  Baseline to Week 4

• Change in ESS Score From Baseline to Week 1, Week 4, and Week 8

  Baseline to Weeks 1, 4, and 8

• Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8

  Weeks 1, 4, and 8

Study Arms (5)

37.5 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

75 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

150 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

300 mg of JZP-110

ACTIVE COMPARATOR

Once Daily Dosing

Drug: JZP-110

Placebo

ACTIVE COMPARATOR

Once Daily Dosing

Drug: Placebo oral tablet

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (59)

Pulmonary Associates

Glendale, Arizona, 85306, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

UC San Diego Medical Center

La Jolla, California, 92037, United States

Location

So Cal Institute For Respiratory Diseases, Inc.

Los Angeles, California, 90048, United States

Location

Pacific Sleep Medicine

Oceanside, California, 92054, United States

Location

Stanford University Center for Narcolepsy

Redwood City, California, 94063, United States

Location

Pacific Research Network, Inc.

San Diego, California, 92103, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

Florida Pediatric Research Institute

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

SleepMed of Central Georgia

Macon, Georgia, 31201, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago College of Nursing

Chicago, Illinois, 60612, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Neurocare, Inc.

Newton, Massachusetts, 24590, United States

Location

Henry Ford Hospital Sleep Disorders & Research Center

Detroit, Michigan, 48202, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

Sleep Medicine & Research Center, St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

University of Missouri

Columbia, Missouri, 65201, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Clinilabs

New York, New York, 10019, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Hickory Research Center

Hickory, North Carolina, 28602, United States

Location

Hickory Research Center, ARSM Research, LLC

Huntersville, North Carolina, 28078, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Northcoast Clinical Trials Inc.

Beachwood, Ohio, 44122, United States

Location

Sleep Management Institute

Cincinnati, Ohio, 45245, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45255, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Southwest Cleveland Sleep Research Center

Cleveland, Ohio, 44130, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Sleep Medicine & Neuroscience Institute

Dublin, Ohio, 43017, United States

Location

Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

Toledo, Ohio, 43606, United States

Location

Sleep Med of South Carolina

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Neurology LP

Austin, Texas, 78731, United States

Location

Todd J. Swick

Houston, Texas, 77063, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Niagra Clinical Research

Niagra Falls, Ontario, L2E 7H9, Canada

Location

Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Location

Toronto Psychiatric Research Foundation

Toronto, Ontario, M5K 2A7, Canada

Location

Pediatric Sleep Research Inc.

Toronto, Ontario, M6J 3S3, Canada

Location

Hospital Roger Salengro

Lille, 59000, France

Location

Universite Paris 5 Hôtel-Dieu

Paris, 75004, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum

Regensburg, Bavaria, 93053, Germany

Location

Universitätsklinikum Münster Department für Neurologie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Advanced Sleep Research GmbH

Berlin, 10117, Germany

Location

Studienzentrum Wilhelmshoehe

Kassel, 34131, Germany

Location

Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, 19053, Germany

Location

Sleep Wake Center SEIN Heemstede

Heemsteded, North Holland, 2103 SW, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 34283019 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.

  PMID: 33631141 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.

  PMID: 33394323 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.

  PMID: 33226332 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.

  PMID: 32353246 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.

  PMID: 30521757 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Director, Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

ClinicalTrialDisclosure@JazzPharma.com

2158709177

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 28, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Locations

FR (3); NL (1); CA (5); US (45); DE (5)