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

Cephalon

Status and phase: Completed; Phase 3

Conditions: Excessive Sleepiness

Treatments: Drug: placebo; Drug: armodafinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758498

C10953/3065/ES/MN

Details and patient eligibility

About

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.

Enrollment: 427 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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427 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

armodafinil - dosage of 50 mg/day

Treatment:

Drug: armodafinil

Drug: armodafinil

2

Experimental group

Description:

armodafinil - dosage of 150 mg/day

Treatment:

Drug: armodafinil

Drug: armodafinil

3

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: placebo