"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Narcolepsy
• Intervention / Treatment: Drug: JZP-110

• Study Type: Interventional
• Enrollment (Actual): 645
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Niagra Falls, Ontario, Canada, L2E 7H9
      • Niagra Clinical Research
    • Toronto, Ontario, Canada, M4P 1P2
      • Toronto Sleep Institute
    • Toronto, Ontario, Canada, m5K 2A7
      • Toronto Psychiatric Research Foundation
    • Toronto, Ontario, Canada, M6J 3S3
      • Pediatric Sleep Research Inc
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • CARSM Sleep Laboratory & Clinic
• Finland
  • Tampere, Finland, 33200
    • Unesta Research Center
  • Turku, Finland, 20520
    • University of Turku , Sleep Research Centre
• France
  • Dijon, France, 21000
    • CHU de Dijon
  • La Tronche, France, 38700
    • Grenoble University Hospital
  • Lille, France, 59000
    • Hospital Roger Salengro
  • Paris, France, 75018
    • Hôpital Bichat - Claude Bernard
  • Paris, France, 75004
    • Universite Paris 5 Hôtel-Dieu
  • Poitiers, France, 86000
    • Chu de Poitiers
• Germany
  • Dortmund, Germany, 44263
    • Somnolab Dortmund
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin GmbH
• Netherlands
  • Noord Holland
    • Heemstede, Noord Holland, Netherlands, 2103 SW
      • Sleep Wake Center SEIN Heemstede
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Medical Center
    • Los Angeles, California, United States, 90048
      • So Cal Institute For Respiratory Diseases, Inc.
    • Oceanside, California, United States, 92054
      • Pacific Sleep Medicine
    • Oceanside, California, United States, 92056
      • The Research Center of Southern California
    • Redwood City, California, United States, 94063
      • Stanford University Center for Narcolepsy
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System
    • San Diego, California, United States, 92103
      • Pacific Research Network Inc.
    • Santa Monica, California, United States, 90404
      • Santa Monica Clinical Trials
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Critical care Pulmonary & Sleep Associates, LLC
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research, LLC
    • Saint Petersburg, Florida, United States, 33707
      • Clinical Research Group of St. Petersburg
    • Winter Park, Florida, United States, 32789
      • Florida Pediatric Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research Inc.
    • Atlanta, Georgia, United States, 30329
      • Emory Sleep Center
    • Macon, Georgia, United States, 31201
      • SleepMed of Central Georgia
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Nursing School
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Rowe Neurology Institute RNI - Lenexa
    • Topeka, Kansas, United States, 66606
      • Veritas Clinical Specialties LTD
  • Kentucky
    • Louisville, Kentucky, United States, 402318
      • Kentucky Research Group
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Advanced Neurodiagnostic Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Hospital
    • Chevy Chase, Maryland, United States, 20815
      • The Center for Sleep & Wake Disorders
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Newton, Massachusetts, United States, 24590
      • Neurocare, Inc.
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital Sleep Disorders & Research Center
    • Sterling Heights, Michigan, United States, 48314
      • Clinical Neurophysiology Services
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Lung Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Sleep Medicine & Research center, St. Lukes Hospital
    • Columbia, Missouri, United States, 65201
      • University of Missouri
    • Saint Louis, Missouri, United States, 63143
      • Clayton Sleep Institute
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10016
      • New York University Medical Center
    • New York, New York, United States, 10019
      • Clinilabs
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Hickory, North Carolina, United States, 28602
      • Hickory Research Center
    • Huntersville, North Carolina, United States, 28078
      • Hickory Research Center, ARSM Research, LLC
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • NorthCoast Clinical Trials Inc.
    • Cincinnati, Ohio, United States, 45245
      • Sleep Management Institute
    • Cincinnati, Ohio, United States, 45255
      • CTI Clinical Research Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Cleveland, Ohio, United States, 44130
      • Southwest Cleveland Sleep Research Center
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine & Neuroscience Institute
    • Toledo, Ohio, United States, 43606
      • Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Center for Sleep and Circadian Neurobiology
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Sleep Medicine Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung Critical Care
    • Columbia, South Carolina, United States, 29201
      • Sleep Med of South Carolina Clinical Research Solutions
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology LP
    • Houston, Texas, United States, 77063
      • Todd J. Swick
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy & Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • EVMS Sleep Medicine
    • Vienna, Virginia, United States, 22182
      • American Sleep Medicine
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Major Inclusion Criteria:

1. Subject meets one of the following:

   1. Completed Study 14-002 or 14-003 (Group A)
   2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to <45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. 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 narcolepsy or 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. 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 or safety 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 roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 75 mg - 300 mg of JZP-110; Once Daily Dosing	Drug: JZP-110

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Epworth Sleepiness Scale (ESS) Score	Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. 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. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.	Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)	Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.	Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)	Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.	Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals

Publications and helpful links

General Publications

• Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.
• Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.
• Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness; Narcolepsy
• Other Study ID Numbers: 14-005