Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

427 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Excessive Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

armodafinil - dosage of 50 mg/day

Group Type EXPERIMENTAL

armodafinil

Intervention Type DRUG

50 mg/day orally, once daily in the morning for 3 days

2

armodafinil - dosage of 150 mg/day

Group Type EXPERIMENTAL

armodafinil

Intervention Type DRUG

150 mg/day orally, once daily in the morning for 3 days

3

matching placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo tablets, once daily in the morning for 3 days

Interventions

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armodafinil

50 mg/day orally, once daily in the morning for 3 days

Intervention Type DRUG

armodafinil

150 mg/day orally, once daily in the morning for 3 days

Intervention Type DRUG

placebo

placebo tablets, once daily in the morning for 3 days

Intervention Type DRUG

Eligibility Criteria

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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

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 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes