Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associ⦠(NCT00758498) | Clinical Trial Compass
CompletedPhase 3
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
United States427 participantsStarted 2008-09
Plain-language summary
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
Who can participate
Age range18 Years ā 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* History of jet lag symptoms during the past 5 years.
* The subject is in good health, as determined by a medical and psychiatric history, medical examination, clinical laboratory test results, and electrocardiography (ECG) and physical examination findings.
* Women of childbearing potential must be abstinent or use a medically accepted method of contraception, and must continue use of this method for the duration of the study (and for 30 days after participation in the study).
* The subject is willing to comply with study restrictions and remain at the study center overnight, as required.
* The subject must agree to refrain from alcohol use during the study.
* The subject has a valid U.S. passport
Key Exclusion Criteria:
* The subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), or any other sleep disorder associated with excessive daytime sleepiness; or the subject has a history or current diagnosis of hypersomnia, insomnia, or sleep disorder.
* The subject has any serious acute or chronic cardiovascular, pulmonary, gastrointestinal, neurological, endocrine or renal illness (including diabetes mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant significant medical condition.
* The subject has a history of any cutaneous drug reaction or drug hypersensitivity, or any clinically significant hyperā¦
What they're measuring
1
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2
Timeframe: Days 1 and 2
2
Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2