"Twelve-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; Drug: Placebo oral tablet

• Registration Number: NCT02348606
• Lead Sponsor: Jazz Pharmaceuticals

Brief Summary

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group 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: 2016-12
• Study Completion: 2016-12
• 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: 2019-07
• Results First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-21
• Results First Posted: 2019-07-23
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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, safety, PK 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 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
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
300 mg of JZP-110	JZP-110	Once Daily Dosing
37.5 mg of JZP-110	JZP-110	Once Daily Dosing
150 mg of JZP-110	JZP-110	Once Daily Dosing
75 mg of JZP-110	JZP-110	Once Daily Dosing
Placebo	Placebo oral tablet	Once Daily Dosing

Primary Outcome Measures

Name	Time	Method
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	Baseline to Week 12	Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Change in ESS Score From Baseline to Week 12	Baseline to Week 12	Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. 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 baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12	Baseline and Week 12	Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12	12 Weeks	Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.; This is the key secondary endpoint.
Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4	Baseline to Week 4	Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.
Change in ESS Score From Baseline to Week 1, Week 4, and Week 8	Baseline to Weeks 1, 4, and 8	Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. 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 baseline.
Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8	Weeks 1, 4, and 8	Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.
Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12	Week 12	Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. 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.
Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8	Weeks 1, 4, and 8	Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. 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.

Trial Locations

Locations (59)

Pulmonary Associates; 🇺🇸 Glendale, Arizona, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

UC San Diego Medical Center; 🇺🇸 La Jolla, California, United States

So Cal Institute For Respiratory Diseases, Inc.; 🇺🇸 Los Angeles, California, United States

Pacific Sleep Medicine; 🇺🇸 Oceanside, California, United States

Stanford University Center for Narcolepsy; 🇺🇸 Redwood City, California, United States

Pacific Research Network, Inc.; 🇺🇸 San Diego, California, United States

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

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

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