"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA" (OSA)
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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.
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)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Major Inclusion Criteria:
Male or female between 18 and 75 years of age, inclusive
Diagnosis of OSA according to ICSD-3 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent
Major Exclusion Criteria:
Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
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.
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Received an investigational drug in the past 30 days or five half-lives
Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products