Treatment of excessive sleepiness in adult patients with obstructive sleep apnea
Conditions
Sponsors
Jazz Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Each subject must meet the following criteria to be enrolled in the study. 1. Male or female between 18 and 75 years of age, inclusive. 2. Diagnosis of OSA according to ICSD-3 criteria. 3. Subject report (with clinician concurrence) of at least minimal use of a primary therapy for OSA or an attempt to use a primary therapy for OSA as follows: a. Use of a primary therapy for OSA (e.g., positive airway pressure, oral appliance) on at least 1 night/week, or b. History of at least 1 month of an attempt to use one or more primary OSA therapies with at least one documented adjustment that was made in an attempt to optimize the primary OSA therapy, or c. History of a surgical intervention intended to treat OSA symptoms. 4. Subject report (with clinician concurrence) of a stable level of compliance with a primary OSA therapy for at least 1 month prior to the Titration Phase as follows: a. A stable level of use of a primary OSA therapy, or b. A lack of use of a primary OSA therapy following a history of attempted use, or c. A history of a surgical intervention intended to treat OSA symptoms. 5. Epworth Sleepiness Scale (ESS) score =10 at the beginning of the Titration Phase. 6. Mean sleep latency =30 minutes as documented by the mean of the first four trials of the MWT at the beginning of the Titration Phase. 7. Usual nightly total sleep time of at least 6 hours. 8. Body mass index from 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects who demonstrate any of the following will be excluded from the study. 1. Unwilling to attempt to use one or more primary OSA therapies. 2. Female subjects who are pregnant, nursing, or lactating. 3. Usual bedtime later than 1 AM (0100 hours). 4. Occupation requiring nighttime shift work or variable shift work. 5. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness. 6. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM 5 criteria. 7.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 Investigator. 8. History of bariatric surgery within the past year or a history of any gastric bypass procedure. 9. Presence of renal impairment or creatinine clearance 600 mg/day of caffeine. 15. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness within 7 days prior to the Titration Phase, or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded medications include OTC sleep aids or stimulants (e.g., pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pemoline, trazodone, hypnotics, benzodiazepines, barbiturates, and opioids. Medications should be discontinued such that the subject has returned to his/her baseline level of daytime sleepiness at least 7 days prior to the Titration Phase, in the opinion of the Investigator. 16. Use of a monoamine oxidase inhibitor (MAOI) in the past 14 days or five half-lives (whichever is longer) before the Titration Phase, or plans to use an MAOI during the study. 17. Received an investigational drug in the past 30 days or five half-lives (whichever is longer) before the Titration Phase assessments, or plans to use an investigational drug (other than the study drug) during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of JZP-110 administered once daily compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.;Secondary Objective: To evaluate the safety and tolerability of JZP-110 administered once daily for up to 6 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.;Primary end point(s): Co-primary Efficacy Endpoints: • MWT: Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40 minute MWT from the end of the Stable Dose Phase (Week 4) to the end of the Double-blind Withdrawal Phase (Week 6) • ESS: Change in ESS score from the end of the Stable Dose Phase (Week 4) to the end of the Double-blind Withdrawal Phase (Week 6) ;Timepoint(s) of evaluation of this end point: Evaluation will be made at weeks 4 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoint: • PGIc: Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase (Week 6) Additional Secondary Endpoints • CGIc: Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase (Week 6) • FOSQ-10: Change in the total score from the beginning of the Titration Phase (Day 1) to the end of the Stable Dose Phase (Week 4) and from the end of the Stable Dose Phase (Week 4) to the end of the Double-blind Withdrawal Phase (Week 6) Exploratory Endpoints • Change in the frequency of use of primary OSA therapy from the beginning of the Titration Phase (Day -1) to the end of the Stable Dose Phase (Week 4) and from the end of the Stable Dose Phase (Week 4) to the end of the Double-blind Withdrawal Phase (Week 6) • Change in PSG parameters including total sleep time (TST), time in Stages N1, N2, N3, wake after sleep onset (WASO), number of awakenings, AI, AHI, central apneas, SaO2 nadir, and SaO2 mean from the end of the Stable Dose Phase (Week 4) to the end of the Double-blind Withdrawal Phase (Week 6) Safety Endpoints To evaluate the safety and tolerability evaluations as determined by the occurrence of and/or changes in: • Treatment-emergent adverse events • Change in clinical laboratory tests (chemistry, hematology, and urinalysis) • Vital signs • 12-lead electrocardiograms (ECGs) • Physical examination • C-SSRS ;Timepoint(s) of evaluation of this end point: Evaluation will be made at weeks 4 and 6 | — |
Countries
Canada, Finland, France, Germany, Sweden, United States
Contacts
Public ContactMichael Nelson
Jazz Pharmaceuticals Inc.
Outcome results
None listed