Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression

Major Depressive Disorder Clinical Trial

Official title:

Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518986
• Other study ID #: C10953/4024/ES/US
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2007
• Last updated: July 12, 2013
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)

• Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective

• Current or prior diagnosis of major depressive disorder or dysthymic disorder

• Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy

• Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening

• Women of childbearing potential must use a medically accepted method of contraception.

Exclusion Criteria:

• Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)

• Current episode of major depression that is considered to be treatment-resistant

• A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis

• Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.

• Patient has a history of homicidal ideation or significant aggression

• Patient has a diagnosis of severe antisocial or borderline personality disorder

• Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm.

• Patient has a history consistent with fibromyalgia or chronic fatigue syndrome

• A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day

• Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction

• Has a past or present seizure disorder

• Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine)

• Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit.

• Patient has known human immunodeficiency virus (HIV)

• Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated)

• Patient is a pregnant or lactating woman

• Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Disorders of Excessive Somnolence
• Dysthymic Disorder
• Major Depressive Disorder
• Obstructive Sleep Apnea
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorders

Intervention

Drug:
• armodafinil
200 mg/day
• placebo
placebo

Locations

Country	Name	City	State
United States	Neurotrials Research, Inc	Atlanta	Georgia
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	The Sleep Disorders Center	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research	Bellevue	Washington
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	PAB Clinical Research	Brandon	Florida
United States	Sleep Health Centers	Brighton	Massachusetts
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Lowcountry Lung and Critical Care	Charleston	South Carolina
United States	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland
United States	Chicago Research Center	Chicago	Illinois
United States	Tri-State Sleep Disorders Center	Cincinnati	Ohio
United States	Sleep Lab of Northeastern PA	Clarks Summit	Pennsylvania
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Community Research	Crestview	Kentucky
United States	Sleep Medicine Associates of Texas, P.A.	Dallas	Texas
United States	The Center for Sleep and Wake Disorders	Danville	Indiana
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	AccelRx Research	Fall River	Massachusetts
United States	Behavioral Research Specialists	Glendale	California
United States	California Clinical Trials Medical Group, Inc.	Glendale	California
United States	The Center for Sleep Medicine	Hattiesburg	Mississippi
United States	Clinical Trials of America	Hickory	North Carolina
United States	Baylor College of Medicine VAMC Sleep Research	Houston	Texas
United States	Houston Sleep Center	Houston	Texas
United States	Jasper Summit Research, LLC	Jasper	Alabama
United States	AccelRx Research	Lincoln	Rhode Island
United States	Somnos Sleep Center	Lincoln	Nebraska
United States	SleepMed, Inc	Macon	Georgia
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Sleep Medicine of Middle Tennessee	Nashville	Tennessee
United States	Clinilabs, Inc	New York City	New York
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Vince & Associates Clinical Research	Overland Park	Kansas
United States	Peoria Pulmonary Associates	Peoria	Illinois
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	University of Pennsylvania Center for Sleep	Philadelphia	Pennsylvania
United States	Psypharma Clinical Research	Phoenix	Arizona
United States	Pulmonary Associates, P.A.	Phoenix	Arizona
United States	Pacific Sleep Medicine Services, Inc.	Redlands	California
United States	California Clinical Trials Medical Group, Inc.	San Diego	California
United States	Pacific Research Network, Inc.	San Diego	California
United States	Pacific Sleep Medicine Services, Inc.	San Diego	California
United States	SDS Clinical Research	Santa Ana	California
United States	St. Johns Medical Plaza Sleep Disorders Center	Santa Monica	California
United States	Pacific Sleep Medicine Services, Inc.	Seattle	Washington
United States	Clinical Trials of America	Shreveport	Louisiana
United States	Florida Sleep Institute	Spring Hill	Florida
United States	Washington University	St. Louis	Missouri
United States	Clinical Research Group of St. Petersburg	St. Petersburg	Florida
United States	SomnoMedics	Tampa	Florida
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	PsyPharm Clinical Research, Inc.	Tucson	Arizona
United States	Sleep and Behavior Medicine	Vernon Hills	Illinois
United States	University Services	West Chester	Pennsylvania
United States	Sleep Medicine Centers	West Seneca	New York
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado
United States	Florida Pulmonary Research Center, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.	Baseline and 12 weeks (or last observation after baseline)	No
Primary	Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.	12 weeks (or last observation after baseline)	No
Secondary	Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)	For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.	Baseline and 12 weeks (or last observation after baseline)	No
Secondary	Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.	baseline and 4 weeks	No
Secondary	Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.	Baseline and 8 weeks following start of study drug administration	No
Secondary	Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks	MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.	baseline and 12 weeks (or last observation after baseline)	No
Secondary	Clinical Global Impression of Change (CGI-C) at 4 Weeks	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed.	4 weeks after beginning study drug treatment	No
Secondary	Clinical Global Impression of Change (CGI-C) at 8 Weeks	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed.	8 weeks after beginning study drug treatment	No
Secondary	Clinical Global Impression of Change (CGI-C) at 12 Weeks	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.	12 weeks after beginning treatment	No
Secondary	Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.	4 weeks after start of treatment	No
Secondary	Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.	8 weeks after start of study drug treatment	No
Secondary	Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale	The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.	12 weeks after starting study drug treatment	No
Secondary	Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.	Baseline and 2 weeks following start of study drug administration	No
Secondary	Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.	Baseline and 4 weeks after start of study drug administration	No
Secondary	Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.	Baseline and 8 weeks after start of study drug administration	No
Secondary	Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.	12 weeks (or last observation after baseline)	No
Secondary	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.	2 weeks	No
Secondary	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.	4 weeks	No
Secondary	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.	8 weeks	No
Secondary	Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks	ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.	12 weeks	No
Secondary	Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.	Baseline and 12 weeks following start of study drug administration or last recorded observation	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.	Baseline and 2 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.	Baseline and 4 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.	Baseline and 8 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.	Baseline and 12 weeks after start of study drug administration	No
Secondary	Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).	Baseline and 12 weeks or last observation after baseline	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.	Baseline and 2 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.	Baseline and 4 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.	Baseline and 8 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks	The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.	12 weeks	No
Secondary	Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.	12 weeks after start of study drug administration (or last observation after baseline)	No
Secondary	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.	2 weeks after start of study drug administration	No
Secondary	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.	4 weeks after start of study drug administration	No
Secondary	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.	8 weeks after start of study drug administration	No
Secondary	Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.	12 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.	Baseline and at endpoint (12 weeks or last observation after baseline)	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.	Baseline and 2 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.	Baseline and 4 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.	Baseline and 8 weeks after start of study drug administration	No
Secondary	Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)	The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.	Baseline and 12 weeks after start of study drug administration	No
Secondary	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.	Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)	No
Secondary	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.	baseline and 2 weeks following start of study drug administration	No
Secondary	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.	baseline and 4 weeks following start of study drug administration	No
Secondary	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.	baseline and 8 weeks following start of study drug administration	No
Secondary	Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.	baseline and 12 weeks following the start of study drug administration	No
Secondary	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.	Endpoint (week 12 or last observation after baseline)	No
Secondary	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.	2 weeks following start of study drug administration	No
Secondary	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.	4 weeks following start of study drug administration	No
Secondary	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.	8 weeks following start of study drug administration	No
Secondary	Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12	The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.	12 weeks following the start of study drug administration	No
Secondary	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline).	Baseline and Endpoint (12 weeks or last observation after baseline)	No
Secondary	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks.	baseline and 2 weeks	No
Secondary	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks.	baseline and 4 weeks following start of study drug administration	No
Secondary	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks.	baseline and 8 weeks following start of study drug administration	No
Secondary	Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks	The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks.	baseline and 12 weeks following start of study drug administration	No
Secondary	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)	The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of "Sleepiness".	Baseline and Endpoint (12 weeks or last observation after baseline)	No
Secondary	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of "Sleepiness".	Baseline and 2 weeks	No
Secondary	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of "Sleepiness".	Baseline and 4 weeks following start of study drug administration	No
Secondary	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of "Sleepiness".	baseline and 8 weeks following start of study drug administration	No
Secondary	Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks	Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of "Sleepiness".	Baseline and 12 weeks following start of study drug administration	No