A clinical trial undertaken around the world in adult patients with excessive daytime sleepiness . These patients are randomly given a drug or an inactive drug to increase their ability to stay awake throughout the day.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Each subject must meet the following criteria to be enrolled in the study:

1. Males and females between 18 and 75 years of age, inclusive.
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria.
3. Baseline mean sleep latency =25 minutes as documented by the mean of the first four trials of the Baseline 5-trial MWT.
4. Baseline Epworth Sleepiness Scale (ESS) score =10.
5. Usual nightly total sleep time of at least 6 hours.
6. Body mass index from 18 to <45 kg/m2.
7. Consent to use a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug, throughout the entire study period, and for 30 days after the study is completed.
8. Willing and able to comply with the study design schedule and other requirements.
9. Willing and able to provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 223
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

1. Female subjects who are pregnant, nursing, or lactating.
2. Usual bedtime later than 1 AM (0100 hours).
3. Occupation requiring nighttime or variable shift work.
4. Moderate or severe obstructive sleep apnea (OSA) on the baseline PSG.
5. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness.
6. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according toDSM-5 criteria.
7. 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.
8. History of bariatric surgery within the past year or a history of any gastric bypass procedure.
9. Presence of renal impairment or calculated creatinine clearance <60 mL/min.
10. Clinically significant ECG abnormality, in the opinion of the Investigator.
11. This criteria has been removed.
12. Presence of significant cardiovascular disease including but not limited to: myocardial infartion within the past year, unstable angina pectoris, symptomatic congestive heart failure (ACC/AHA stage C or D), revascularization procedures within the past year, ventricular cardiac arrhythmias requiring automatic implantable cardioverter defibrillatory (AICD) or medication therapy, uncontrolled hypertension, systolic blood pressure =155 mmHg or diastolic blood pressure =95 mmHg (at screening, or consistently across Baseline measures according to protocol specifications), or any history of cardiovascular disease or any significant cardiovascular condition that in the investigator's opinion may jeopardize subject safety in the study.
13. Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, and urinalysis); NOTE: Screening labs may be repeated once.
14. Excessive caffeine use one week prior to Baseline assessments or anticipated excessive use during the study defined as >600 mg/day of caffeine.
15. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness within 7 days prior to the Baseline visit, or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded medications include OTC sleep aids orstimulants (e.g., pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pemoline, trazodone, hypnotics, benzodiazepines, barbiturates, and opioids. Medications should be discontinued such that the subject has returned to his/her baseline level of daytime sleepiness at least 7 days prior to the Baseline visit, in the opinion of the Investigator.
16. Use of any medications that could affect the evaluation of cataplexy within 7 days prior to the Baseline visit, or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded anti-cataplectic medications include selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), anti-convulsant agents, and sodium oxybate.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallelgroup, 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

CompletedPhase 3

Jazz Pharmaceuticals Inc.

Updated 4/23/2024