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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02348606
• Date of registration: 15/01/2015
• Prospective Registration: Yes
• Primary sponsor: Jazz Pharmaceuticals
• Public title: "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA" OSA
• Scientific title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, 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)
• Date of first enrolment: May 2015
• Target sample size: 476
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02348606
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, France, Germany, Netherlands, United States

Key inclusion & exclusion 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, 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obstructive Sleep Apnea

Intervention(s)

Drug: JZP-110

Drug: Placebo oral tablet

Primary Outcome(s)

Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 [Time Frame: Baseline to Week 12]

Change in ESS Score From Baseline to Week 12 [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12 [Time Frame: Baseline and Week 12]

Change in ESS Score From Baseline to Week 1, Week 4, and Week 8 [Time Frame: Baseline to Weeks 1, 4, and 8]

Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4 [Time Frame: Baseline to Week 4]

Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8 [Time Frame: Weeks 1, 4, and 8]

Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8 [Time Frame: Weeks 1, 4, and 8]

Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12 [Time Frame: Week 12]

Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 [Time Frame: 12 Weeks]

Secondary ID(s)

14-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02348606