"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: JZP-110

• Registration Number: NCT02348619
• Lead Sponsor: Jazz Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Study Start: 2015-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Disposition First Submitted: 2017-11-16
• Disposition First Submitted QC: 2017-11-16
• Disposition First Posted: 2017-11-20
• Results First Submitted: 2019-04-19
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Results First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
75, 150, 300 mg of JZP-110	JZP-110	Once Daily Dosing
Placebo	JZP-110	Once Daily Dosing

Primary Outcome Measures

Name	Time	Method
Change in the Maintenance of Wakefulness Test (MWT)	Week 4 to Week 6	Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Change in the Epworth Sleepiness Scale (ESS)	Week 4 to Week 6	Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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. The response variable was the change in ESS score from week 4 to week 6.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIc)	Week 4 to Week 6	Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Clinical Global Impression of Change (CGIc)	Week 4 to Week 6	Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)	Week 4 to Week 6	Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities.

Trial Locations

Locations (30)

Broward Research Group, Inc.; 🇺🇸 Hollywood, Florida, United States

Emory Sleep Center; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

UPMC Sleep Medicine Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Klinische Forschung Schwerin GmbH; 🇩🇪 Schwerin, Mecklenburg-Vorpommern, Germany

CHU de Poitiers; 🇫🇷 Poitiers, Vienne, France

EVMS Sleep Medicine; 🇺🇸 Norfolk, Virginia, United States

Grenoble University Hospital; 🇫🇷 La Tronche, Rhône-Alpes, France

Santa Monica Clinical Trials; 🇺🇸 Santa Monica, California, United States

SDS Clinical Trials, INC; 🇺🇸 Orange, California, United States

Critical Care Pulmonary & Sleep Associates, LLC; 🇺🇸 Lakewood, Colorado, United States

Veritas Clinical Specialities LTD; 🇺🇸 Topeka, Kansas, United States

Oviedo Medical Research, LLC; 🇺🇸 Oviedo, Florida, United States

PMG Research of Wilmington; 🇺🇸 Wilmington, North Carolina, United States

Tampere University Hospital; 🇫🇮 Tampere, Södra Finlands Län, Finland

Turku University Hospital, Sleep Clinic; 🇫🇮 Turku, Västra Finlands Län, Finland

Helsinki Sleep Center; 🇫🇮 Helsinki, Finland

The Research Center of Southern California; 🇺🇸 Oceanside, California, United States

PAB Clinical Research; 🇺🇸 Brandon, Florida, United States

Center for Sleep & Circadian Neurobiology; 🇺🇸 Philadelphia, Pennsylvania, United States

American Sleep Medicine; 🇺🇸 Vienna, Virginia, United States

Rowe Neurology Institute RNI - Lenexa; 🇺🇸 Lenexa, Kansas, United States

Department of Sleep Medicine; 🇸🇪 Gӧteborg, Västra Götalands Län, Sweden

Advanced Neurodiagnostic Ceneter; 🇺🇸 Metairie, Louisiana, United States

Somnolab Dortmund; 🇩🇪 Dortmund, Nordrhein-Westfalen, Germany

Sleep Disorder Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Brigham & Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Lowcountry Lung Critical Care; 🇺🇸 Charleston, South Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States