A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA

Study Overview
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Brief Summary
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This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

Official Title
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A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

Conditions
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Narcolepsy, Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: JZP-110


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Subject meets one of the following: Completed Study 14-002 or 14-003 (Group A) Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B) 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 narcolepsy or 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 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 Investigator History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer) History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 75 mg - 300 mg of JZP-110<br>Once Daily Dosing | Drug: JZP-110<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Epworth Sleepiness Scale (ESS) Score | Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period. | Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) | 
| Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) |