Status:
COMPLETED
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Lead Sponsor:
Cephalon
Conditions:
Excessive Sleepiness
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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 hypersensitivity reaction, or multiple allergies.
- The subject has a history of deep vein thrombosis (DVT).
- The subject has known human immunodeficiency virus (HIV).
- The subject is pregnant or lactating.
- The subject has used nicotine within the last 3 months.
- The subject has a history of seizures, except for a single febrile seizure.
- The subject has a psychiatric disorder that would affect participation in the study or full compliance with study procedures.
- The subject has a clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings.
- The subject used any prescription or over the counter drugs disallowed by the protocol within 7 days of screening visit 2 (i.e., stimulants, hypnotics).
- The subject has used an investigational drug within 1 month before the screening visit.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- The subject has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT00758498
Start Date
September 1 2008
End Date
February 1 2009
Last Update
July 19 2013
Active Locations (4)
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1
Neurotrials Research, Inc.
Atlanta, Georgia, United States, 30342
2
Community Research
Crestview, Kentucky, United States, 45217
3
Clinilabs, Inc.
New York, New York, United States, 10019
4
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201