A long term clinical trial undertaken around the world in adult patients to treat Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea
- Conditions
- Treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apneato increase the ability to stay awake throughout the day.MedDRA version: 18.0Level: HLTClassification code 10028716Term: Narcolepsy and associated conditionsSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-005489-31-FR
- Lead Sponsor
- Jazz Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria:
All subjects must meet the following criteria to be enrolled in the study.
1. Subject meets one of the following:
a. Completed Study 14-002 or 14-003 (Group A)
b. Completed Study ADX-N05 201 or ADX-N05 202 (Group B)
2. Subject is able, in the opinion of the investigator, to take JZP-110 for 40 weeks if continuing from 14-002 or 14-003 or for 52 weeks if the subject completed ADX-N05 201 or ADX-N05 202, and is able to complete all tests and visits described in this protocol.
3. Usual nightly total sleep time of at least 6 hours.
4. Body mass index from 18 to <40 kg/m2.
5. 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.
6. Willing and able to comply with the study design schedule and other requirements.
7. 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 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria:
Subjects who demonstrate any of the following will be excluded from the study.
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. Experienced any serious adverse event (SAE) in a previous study that was deemed related to JZP-110 or experienced an AE in a previous study that might prevent him/her from safely participating in and completing the current study.
5. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA 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 to DSM-5 criteria.
7. 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 or safety 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 or >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 of the drug (whichever is longer) before administration of the first dose of the study drug.
12. Presence or history 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 Baseline 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 the Baseline Visit or anticipated excessive use during the study defined as >600 mg/day of caffeine.
15. Use of a monoamine oxidase inhibitor (MAOI) in the past 14 days or five half-lives of the drug (whichever is longer) prior to the Baseline Visit, or plans to use an MAOI during the study.
16. Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer) before the Baseline Visit, or plans to use an investigational drug (other than the study drug) during the study.
17. Current or past (within the past 2 years) diagnosis of a moderate or severe substance use disorder according to DSM-5 criteria.
18. Nicotine dependence that has an effect on sleep (e.g., a subject who routinely awakens at night to smoke).
19. Current, past (within the past 2 years), or seeking treatment for a substance related disorder.
20. Urine drug screen positive
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