Clinical trial NCT02348632: "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Narcolepsy
Obstructive Sleep Apnea
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 645
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Epworth Sleepiness Scale (ESS) Score
timeFrame: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
Secondary outcomes:
measure: Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)
timeFrame: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
measure: Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)
timeFrame: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
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: Oceanside
country: United States
facility: The Research Center of Southern California
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: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Lakewood
country: United States
facility: Critical care Pulmonary & Sleep Associates, LLC
state: Colorado
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
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: Emory Sleep Center
state: Georgia
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 Nursing School
state: Illinois
city: Lenexa
country: United States
facility: Rowe Neurology Institute RNI - Lenexa
state: Kansas
city: Topeka
country: United States
facility: Veritas Clinical Specialties LTD
state: Kansas
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Metairie
country: United States
facility: Advanced Neurodiagnostic Center
state: Louisiana
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: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
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. Lukes 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: New York University 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: Wilmington
country: United States
facility: PMG Research of Wilmington
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: Philadelphia
country: United States
facility: Center for Sleep and Circadian Neurobiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Sleep Medicine Center
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Lung Critical Care
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Sleep Med of South Carolina Clinical Research Solutions
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: Norfolk
country: United States
facility: EVMS Sleep Medicine
state: Virginia
city: Vienna
country: United States
facility: American Sleep Medicine
state: Virginia
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: Montreal
country: Canada
facility: CARSM Sleep Laboratory & Clinic
state: Quebec
city: Tampere
country: Finland
facility: Unesta Research Center
city: Turku
country: Finland
facility: University of Turku , Sleep Research Centre
city: Dijon
country: France
facility: CHU de Dijon
city: La Tronche
country: France
facility: Grenoble University Hospital
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: Poitiers
country: France
facility: CHU de Poitiers
city: Dortmund
country: Germany
facility: Somnolab Dortmund
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Heemstede
country: Netherlands
facility: Sleep Wake Center SEIN Heemstede
state: Noord Holland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.