A clinical trial undertaken around the world for treating excessive daytime sleepiness in subjects with obstructive sleep apnea. 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 obstructive sleep apneato increase the ability to stay awake throughout the day.MedDRA version: 18.1Level: HLTClassification code 10028716Term: Narcolepsy and associated conditionsSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-005514-31-NL
- Lead Sponsor
- Jazz Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria:
Each subject must meet the following criteria to be enrolled in the study.
1. Male or female between 18 and 75 years of age, inclusive.
2. Diagnosis of OSA according to ICSD-3 criteria.
3. Subject report (with clinician concurrence) of at least minimal use of a primary therapy for OSA or an attempt to use a primary therapy for OSA as follows:
a. Use of a primary therapy for OSA (i.e., positive airway pressure or oral appliance) on at least 1 night/week, or
b. History of at least 1 month of an attempt to use one or more primary OSA therapies with at least one documented adjustment that was made in an attempt to optimize the primary OSA therapy, or
c. History of a surgical intervention intended to treat OSA symptoms.
4. Subject report (with clinician concurrence) of a stable level of compliance with a primary OSA therapy for at least 1 month prior to Baseline as follows:
a. A stable level of use of a primary OSA therapy, or
b. A lack of use of a primary OSA therapy following a history of attempted use, or
c. A history of a surgical intervention intended to treat OSA symptoms.
5. Baseline Epworth Sleepiness Scale (ESS) score =10.
6. Baseline mean sleep latency =30 minutes as documented by the mean of the first four trials of the MWT.
7. Usual nightly total sleep time of at least 6 hours.
8. Body mass index from 18 to <45 kg/m2.
9. 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.
10. Willing and able to comply with the study design schedule and other requirements.
11. 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 396
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
Exclusion Criteria
Subjects who demonstrate any of the following will be excluded from the study.
1. Unwilling to attempt to use one or more primary OSA therapies.
2. Female subjects who are pregnant, nursing, or lactating.
3. Usual bedtime later than 1 AM (0100 hours).
4. Occupation requiring nighttime shift work or variable shift work.
5. Any other clinically relevant medical, behavioral, or psychiatric disorder other than 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.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. Clinical 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 infarction 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 an automatic implantable cardioverter defibrillator (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 or stimulants (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 a monoamine oxidase inhibitor (MAOI) in the past 14 days or five half-lives (whichever is longer) prior to the Baseline Visit, or plans to use an MAOI during the study.
17. Received an investigational drug in the past 30 days or five half-lives (whichever is longer) prior to the Baseline Visit, or plans to use an investigational drug (other than the study drug) during the study.
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