Clinical trial NCT00758498: Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Official title: A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Excessive Sleepiness
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Primary outcomes:
measure: 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
measure: Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2
timeFrame: Days 1 and 2
Secondary outcomes:
measure: Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)
timeFrame: Days 1 and 2
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1
timeFrame: Day 1
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2
timeFrame: Day 2
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3
timeFrame: Day 3
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline
timeFrame: Baseline prior to starting study medication
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1
timeFrame: Day 1 bedtime
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2
timeFrame: Day 2 bedtime
measure: Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3
timeFrame: Day 3 bedtime
measure: Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline
timeFrame: Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1
measure: Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1
timeFrame: Day 1
measure: Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2
timeFrame: Day 2
measure: Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3
timeFrame: Day 3
measure: Mean Patient Global Impression of Severity of General Condition Ratings at Baseline
timeFrame: Baseline, prior to start of study drug dosing
measure: Mean Patient Global Impression of Severity of General Condition Ratings at Day 1
timeFrame: Day 1
measure: Mean Patient Global Impression of Severity of General Condition Ratings at Day 2
timeFrame: Day 2
measure: Mean Patient Global Impression of Severity of General Condition Ratings at Day 3
timeFrame: Day 3
measure: Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint
timeFrame: Endpoint defined as either Day 3 or last observation after baseline
measure: Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1
timeFrame: Day 1
measure: Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2
timeFrame: Day 2
measure: Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3
timeFrame: Day 3
measure: Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography
timeFrame: Baseline and Day 2 (Endpoint)
measure: Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography
timeFrame: Baseline and Day 2 (Endpoint)
measure: Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography
timeFrame: Baseline and Day 2 (Endpoint)
measure: Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography
timeFrame: Baseline and Day 2 (Endpoint)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Neurotrials Research, Inc.
state: Georgia
city: Crestview
country: United States
facility: Community Research
state: Kentucky
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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.