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.

• Conditions: Treatment of excessive sleepiness in adult patients with narcolepsy; MedDRA version: 18.0Level: HLTClassification code 10028716Term: Narcolepsy and associated conditionsSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005487-15-FR
• Lead Sponsor: Jazz Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-24
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 70 years of age, inclusive.
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria.
3. Baseline mean sleep latency =10 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 <40 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 unstable or clinically significant 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, or PK assessments per the judgment of the Investigator.
8. History of bariatric surgery within the past year.
9. Presence of renal impairment or calculated creatinine clearance <60 mL/min.
10. History or presence of a risk factor for torsade de pointes (e.g., clinically significant ECG abnormality, QTcF interval of >450 msec for males and >470 msec for females, hypokalemia, family history of long QT syndrome).
11. Use of concomitant medication with known risk for torsade de pointes (e.g., citalopram, escitalopram, azithromycin, clarithromycin, erythromycin,
levofloxacin, moxifloxacin, ondansetron, pimozide, thioridazine) within 14 days or 5 half-lives (whichever is longer) prior to the Baseline visit.
12. History or presence of significant cardiovascular disease including but not limited to: myocardial infarction, uncontrolled hypertension, systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg (at screening, or consistently across Baseline measures according to protocol specifications), angina pectoris, clinically significant arrhythmias, clinically significant valvular heart disease, history of any revascularization procedures or second or third degree heart block with/without a pacemaker, or heart failure.
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 (

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified