Clinical trial NCT02348619: "Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Official title: A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.


Eligibility criteria: Major Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive
2. Diagnosis of OSA according to ICSD-3 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. 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 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. 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 or safety assessments or the ability of the subject to complete the trial per the judgment of the principal investigator
5. History of bariatric surgery within the past year or a history of any gastric bypass 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 in the past 30 days or five half-lives (whichever is longer)
9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
10. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Primary outcomes:
measure: Change in the Maintenance of Wakefulness Test (MWT)
timeFrame: Week 4 to Week 6
measure: Change in the Epworth Sleepiness Scale (ESS)
timeFrame: Week 4 to Week 6
Secondary outcomes:
measure: Patient Global Impression of Change (PGIc)
timeFrame: Week 4 to Week 6
measure: Clinical Global Impression of Change (CGIc)
timeFrame: Week 4 to Week 6
measure: Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
timeFrame: Week 4 to Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorder Center of Alabama
state: Alabama
city: Oceanside
country: United States
facility: The Research Center of Southern California
state: California
city: Orange
country: United States
facility: SDS Clinical Trials, INC
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: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Broward Research Group, Inc.
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Emory Sleep Center
state: Georgia
city: Lenexa
country: United States
facility: Rowe Neurology Institute RNI - Lenexa
state: Kansas
city: Topeka
country: United States
facility: Veritas Clinical Specialities LTD
state: Kansas
city: Metairie
country: United States
facility: Advanced Neurodiagnostic Ceneter
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham & Womens Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Philadelphia
country: United States
facility: Center for Sleep & 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: Norfolk
country: United States
facility: EVMS Sleep Medicine
state: Virginia
city: Vienna
country: United States
facility: American Sleep Medicine
state: Virginia
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Södra Finlands Län
city: Turku
country: Finland
facility: Turku University Hospital, Sleep Clinic
state: Västra Finlands Län
city: Helsinki
country: Finland
facility: Helsinki Sleep Center
city: La Tronche
country: France
facility: Grenoble University Hospital
state: Rhône-Alpes
city: Poitiers
country: France
facility: CHU de Poitiers
state: Vienne
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
state: Mecklenburg-Vorpommern
city: Dortmund
country: Germany
facility: Somnolab Dortmund
state: Nordrhein-Westfalen
city: Gӧteborg
country: Sweden
facility: Department of Sleep Medicine
state: Västra Götalands Län
Study officials:
References:
citation: Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.