Back to results"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Primary Purpose
Narcolepsy, Obstructive Sleep Apnea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
JZP-110
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy
Eligibility Criteria
Major Inclusion Criteria:
Subject meets one of the following:
- Completed Study 14-002 or 14-003 (Group A)
- Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
- 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
Major Exclusion Criteria:
- Female subjects who are pregnant, nursing, or lactating
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or 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
- 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
- History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
- History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Sites / Locations
- Sleep Disorders Center of Alabama
- Pulmonary Associates
- Mayo Clinic in Arizona
- Preferred Research Partners
- UC San Diego Medical Center
- So Cal Institute For Respiratory Diseases, Inc.
- Pacific Sleep Medicine
- The Research Center of Southern California
- Stanford University Center for Narcolepsy
- Pacific Research Network Inc.
- VA San Diego Healthcare System
- Santa Monica Clinical Trials
- Critical care Pulmonary & Sleep Associates, LLC
- MD Clinical
- Oviedo Medical Research, LLC
- Clinical Research Group of St. Petersburg
- Florida Pediatric Research Institute
- Emory Sleep Center
- NeuroTrials Research Inc.
- SleepMed of Central Georgia
- Northwestern University Feinberg School of Medicine
- University of Illinois at Chicago Nursing School
- Rowe Neurology Institute RNI - Lenexa
- Veritas Clinical Specialties LTD
- Kentucky Research Group
- Advanced Neurodiagnostic Center
- Johns Hopkins Hospital
- The Center for Sleep & Wake Disorders
- Brigham and Women's Hospital
- Neurocare, Inc.
- Henry Ford Hospital Sleep Disorders & Research Center
- Clinical Neurophysiology Services
- Minnesota Lung Center
- Sleep Medicine & Research center, St. Lukes Hospital
- University of Missouri
- Clayton Sleep Institute
- Montefiore Medical Center
- New York University Medical Center
- Clinilabs
- Duke University Medical Center
- Hickory Research Center
- Hickory Research Center, ARSM Research, LLC
- Raleigh Neurology Associates
- PMG Research of Wilmington
- Northcoast Clinical Trials Inc.
- Sleep Management Institute
- CTI Clinical Research Center
- Case Western Reserve University
- Southwest Cleveland Sleep Research Center
- Cleveland Clinic
- Ohio Sleep Medicine & Neuroscience Institute
- Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
- Center for Sleep and Circadian Neurobiology
- UPMC Sleep Medicine Center
- Lowcountry Lung Critical Care
- Medical University of South Carolina
- Sleep Med of South Carolina Clinical Research Solutions
- FutureSearch Trials of Neurology LP
- Todd J. Swick
- Sleep Therapy & Research Center
- EVMS Sleep Medicine
- American Sleep Medicine
- Swedish Medical Center
- London Health Sciences Centre
- Niagra Clinical Research
- Toronto Sleep Institute
- Toronto Psychiatric Research Foundation
- Pediatric Sleep Research Inc
- CARSM Sleep Laboratory & Clinic
- Unesta Research Center
- University of Turku , Sleep Research Centre
- CHU de Dijon
- Grenoble University Hospital
- Hospital Roger Salengro
- Universite Paris 5 Hôtel-Dieu
- Hopital Bichat - Claude Bernard
- CHU de Poitiers
- Somnolab Dortmund
- Klinische Forschung Schwerin GmbH
- Sleep Wake Center SEIN Heemstede
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
75 mg - 300 mg of JZP-110
Arm Description
Once Daily Dosing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02348632
Brief Title
"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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
645 (Actual)
8. Arms, Groups, and Interventions
Arm Title
75 mg - 300 mg of JZP-110
Arm Type
Other
Arm Description
Once Daily Dosing
Intervention Type
Drug
Intervention Name(s)
JZP-110
Primary Outcome Measure Information:
Title
Change in Epworth Sleepiness Scale (ESS) Score
Description
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.
Time Frame
Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
Secondary Outcome Measure Information:
Title
Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)
Description
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.
Time Frame
Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Title
Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)
Description
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.
Time Frame
Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria:
Subject meets one of the following:
Completed Study 14-002 or 14-003 (Group A)
Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
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
Major Exclusion Criteria:
Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or 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
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
History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Pulmonary Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
UC San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
So Cal Institute For Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Sleep Medicine
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
The Research Center of Southern California
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Stanford University Center for Narcolepsy
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Pacific Research Network Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Critical care Pulmonary & Sleep Associates, LLC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Oviedo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Clinical Research Group of St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Florida Pediatric Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory Sleep Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroTrials Research Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
SleepMed of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago Nursing School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rowe Neurology Institute RNI - Lenexa
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Veritas Clinical Specialties LTD
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
402318
Country
United States
Facility Name
Advanced Neurodiagnostic Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
The Center for Sleep & Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
24590
Country
United States
Facility Name
Henry Ford Hospital Sleep Disorders & Research Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Clinical Neurophysiology Services
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Sleep Medicine & Research center, St. Lukes Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hickory Research Center
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Hickory Research Center, ARSM Research, LLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Northcoast Clinical Trials Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Sleep Management Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Southwest Cleveland Sleep Research Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Sleep Medicine & Neuroscience Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Mercy St. Anne & Mercy St. Charles Sleep Disorders Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Center for Sleep and Circadian Neurobiology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Sleep Medicine Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lowcountry Lung Critical Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sleep Med of South Carolina Clinical Research Solutions
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
FutureSearch Trials of Neurology LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Todd J. Swick
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
EVMS Sleep Medicine
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
American Sleep Medicine
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Niagra Clinical Research
City
Niagra Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H9
Country
Canada
Facility Name
Toronto Sleep Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
Facility Name
Toronto Psychiatric Research Foundation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
m5K 2A7
Country
Canada
Facility Name
Pediatric Sleep Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 3S3
Country
Canada
Facility Name
CARSM Sleep Laboratory & Clinic
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Unesta Research Center
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
University of Turku , Sleep Research Centre
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Grenoble University Hospital
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hospital Roger Salengro
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Universite Paris 5 Hôtel-Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Somnolab Dortmund
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Sleep Wake Center SEIN Heemstede
City
Heemstede
State/Province
Noord Holland
ZIP/Postal Code
2103 SW
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34606437
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.
Results Reference
derived
PubMed Identifier
33179591
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.
Results Reference
derived
PubMed Identifier
31691827
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.
Results Reference
derived
Learn more about this trial
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
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