Overview

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

Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jazz Pharmaceuticals
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 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