Treatment of excessive sleepiness in adult patients with narcolepsy MedDRA version: 18.1 Level: HLT Classification code 10028716 Term: Narcolepsy and associated conditions System Organ Class: 100000004873
Conditions
Sponsors
Jazz Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must meet the following criteria to be enrolled in the study: 1. Males and females between 18 and 75 years of age, inclusive. 2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria. 3. Baseline mean sleep latency =25 minutes as documented by the mean of the first four trials of the Baseline 5-trial MWT. 4. Baseline Epworth Sleepiness Scale (ESS) score =10. 5. Usual nightly total sleep time of at least 6 hours. 6. Body mass index from 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant, nursing, or lactating. 2. Usual bedtime later than 1 AM (0100 hours). 3. Occupation requiring nighttime or variable shift work. 4. Moderate or severe obstructive sleep apnea (OSA) on the baseline PSG. 5. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy 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 toDSM-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, safety, PK 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 calculated 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 Baseline visit, or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded medications include OTC sleep aids orstimulants (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 Baseline visit, in the opinion of the Investigator. 16. Use of any medications that could affect the evaluation of cataplexy within 7 days prior to the Baseline visit, or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded anti-cataplectic medications include selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), anti-convulsant agents, and sodium oxybat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy.;Secondary Objective: To evaluate the safety and tolerability of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy. To characterize the pharmacokinetics (PK) of JZP-110 in subjects with narcolepsy using sparse sampling methods.;Primary end point(s): Efficacy Endpoints Co-primary Efficacy Endpoint: • MWT: Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 12 • ESS: Change in ESS score from Baseline to Week 12 ;Timepoint(s) of evaluation of this end point: During the Treatment Phase, subjects will return to the investigative site to complete efficacy and safety assessments at the end of Weeks 1, 4, 8, and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoint: • PGIc: Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12 Other Secondary Endpoints: • Time course of efficacy on the MWT: Change in sleep latency time (in minutes) on each of the 5 MWT trials • CGIc: Percentage of subjects reported as improved (minimally, much, or very much) at Week 12 • MWT: Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 1 and Week 4 • ESS: Change in ESS score from Baseline to Week 1, Week 4, and Week 8 • PGIc: Percentage of subjects reported as improved at Week 1, Week 4, and Week 8 • CGIc: Percentage of subjects reported as improved at Week 1, Week 4, and Week 8 Functional Outcomes and Quality of Life Endpoints • FOSQ-10: Change in the total score from Baseline to Week 1, Week 4, Week 8, and Week 12 • SF-36v2: Change in the total score and change in the 8 subscales from Baseline to Week 4, Week 8, and Week 12 o EQ-5D-5L: EQ-5D Dimensions: ?• Number and percentage of subjects in each of the 5 levels (e.g., no problem, slight problem, moderate problem, severe problem, unable) for each dimension (e.g., mobility, self-care) over time ?• Number and percentage of subjects reporting any problems (levels 2-5) for each dimension (e.g., mobility, self-care) over time o EQ VAS: Mean and SD or median with 25th and 75th percentiles for the VAS at Baseline, Week 1, Week 4, Week 8 and Week 12. Change in the mean VAS scores from Baseline to Week 1, Week 4, Week 8, and Week 12 o EQ-5D-5L Index: Index value at Baseline to Week 1, Week 4, Week 8, and Week 12 • WPAI:SHP: Percent work time missed due to problem over time, percent impairment while working due to problem over time, percent overall work impairment due to problem over time, and percent activity impairment due to problem over time Exploratory Endpoints • Number of Cataplexy Attacks: Change | — |
Countries
Canada, Finland, France, Germany, Netherlands, United States
Contacts
Public ContactMichael Nelson
Jazz Pharmaceuticals Inc.
Outcome results
None listed