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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348632
• Other study ID #: 14-005
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2019
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 645
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Narcolepsy
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness

Intervention

Drug:
• JZP-110

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	CARSM Sleep Laboratory & Clinic	Montreal	Quebec
Canada	Niagra Clinical Research	Niagra Falls	Ontario
Canada	Pediatric Sleep Research Inc	Toronto	Ontario
Canada	Toronto Psychiatric Research Foundation	Toronto	Ontario
Canada	Toronto Sleep Institute	Toronto	Ontario
Finland	Unesta Research Center	Tampere
Finland	University of Turku , Sleep Research Centre	Turku
France	CHU de Dijon	Dijon
France	Grenoble University Hospital	La Tronche
France	Hospital Roger Salengro	Lille
France	Hopital Bichat - Claude Bernard	Paris
France	Universite Paris 5 Hôtel-Dieu	Paris
France	CHU de Poitiers	Poitiers
Germany	Somnolab Dortmund	Dortmund
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Netherlands	Sleep Wake Center SEIN Heemstede	Heemstede	Noord Holland
United States	Emory Sleep Center	Atlanta	Georgia
United States	NeuroTrials Research Inc.	Atlanta	Georgia
United States	FutureSearch Trials of Neurology LP	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Northcoast Clinical Trials Inc.	Beachwood	Ohio
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Lowcountry Lung Critical Care	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Sleep Medicine & Research center, St. Lukes Hospital	Chesterfield	Missouri
United States	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	University of Illinois at Chicago Nursing School	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Sleep Management Institute	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Southwest Cleveland Sleep Research Center	Cleveland	Ohio
United States	Sleep Med of South Carolina Clinical Research Solutions	Columbia	South Carolina
United States	University of Missouri	Columbia	Missouri
United States	Henry Ford Hospital Sleep Disorders & Research Center	Detroit	Michigan
United States	Ohio Sleep Medicine & Neuroscience Institute	Dublin	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Minnesota Lung Center	Edina	Minnesota
United States	Pulmonary Associates	Glendale	Arizona
United States	MD Clinical	Hallandale Beach	Florida
United States	Hickory Research Center	Hickory	North Carolina
United States	Todd J. Swick	Houston	Texas
United States	Hickory Research Center, ARSM Research, LLC	Huntersville	North Carolina
United States	UC San Diego Medical Center	La Jolla	California
United States	Critical care Pulmonary & Sleep Associates, LLC	Lakewood	Colorado
United States	Rowe Neurology Institute RNI - Lenexa	Lenexa	Kansas
United States	Preferred Research Partners	Little Rock	Arkansas
United States	So Cal Institute For Respiratory Diseases, Inc.	Los Angeles	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	SleepMed of Central Georgia	Macon	Georgia
United States	Advanced Neurodiagnostic Center	Metairie	Louisiana
United States	Clinilabs	New York	New York
United States	New York University Medical Center	New York	New York
United States	Neurocare, Inc.	Newton	Massachusetts
United States	EVMS Sleep Medicine	Norfolk	Virginia
United States	Pacific Sleep Medicine	Oceanside	California
United States	The Research Center of Southern California	Oceanside	California
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	Center for Sleep and Circadian Neurobiology	Philadelphia	Pennsylvania
United States	UPMC Sleep Medicine Center	Pittsburgh	Pennsylvania
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Stanford University Center for Narcolepsy	Redwood City	California
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Clinical Research Group of St. Petersburg	Saint Petersburg	Florida
United States	Sleep Therapy & Research Center	San Antonio	Texas
United States	Pacific Research Network Inc.	San Diego	California
United States	VA San Diego Healthcare System	San Diego	California
United States	Santa Monica Clinical Trials	Santa Monica	California
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Clinical Neurophysiology Services	Sterling Heights	Michigan
United States	Mercy St. Anne & Mercy St. Charles Sleep Disorders Center	Toledo	Ohio
United States	Veritas Clinical Specialties LTD	Topeka	Kansas
United States	American Sleep Medicine	Vienna	Virginia
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Florida Pediatric Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)