"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
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This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
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 Narcolepsy
Actual 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, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Major Inclusion Criteria:
Males and females between 18 and 75 years of age, inclusive
Diagnosis of narcolepsy according to ICSD-3 or DSM-5 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
Moderate or severe sleep apnea on the baseline PSG.
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy 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 gastic 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
Use of any medications that could affect the evaluation of cataplexy
Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products