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

NCT00758498 | Completed Phase 3 Results

• 1 other identifier: C10953/3065/ES/MN
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 4

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.

Conditions

Excessive Sleepiness

Outcome Measures

Primary Outcomes (2)

• Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2

  MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.

  Days 1 and 2

• Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2

  The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term "ill" refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here.

  Days 1 and 2

Secondary Outcomes (24)

• Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)

  Days 1 and 2

• Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1

  Day 1

• Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2

  Day 2

• Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3

  Day 3

• Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline

  Baseline prior to starting study medication

Study Arms (3)

1

EXPERIMENTAL

armodafinil - dosage of 50 mg/day

Drug: armodafinil

2

EXPERIMENTAL

armodafinil - dosage of 150 mg/day

Drug: armodafinil

3

PLACEBO COMPARATOR

matching placebo

Drug: placebo

Interventions

armodafinil DRUG

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

1

placebo DRUG

placebo tablets, once daily in the morning for 3 days

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (4)

Neurotrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Community Research

Crestview, Kentucky, 45217, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Related Publications (1)

• Rosenberg RP, Bogan RK, Tiller JM, Yang R, Youakim JM, Earl CQ, Roth T. A phase 3, double-blind, randomized, placebo-controlled study of armodafinil for excessive sleepiness associated with jet lag disorder. Mayo Clin Proc. 2010 Jul;85(7):630-8. doi: 10.4065/mcp.2009.0778. Epub 2010 Jun 7.

  PMID: 20530317 DERIVED

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Monitor
• Organization: Cephalon, Inc.

1-800-896-5855

Study Officials

• Sponsor's Medical Expert

  Cephalon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 19, 2013
• Results First Posted: July 8, 2010

Record last verified: 2013-07

Locations

US (4)