Dysthymic Disorder, Major Depressive Disorder, Obstructive Sleep Apnea, Sleep Disorders
Conditions
Keywords
Obstructive Sleep Apnea/Hypopnea Syndrome, Excessive Sleepiness
Brief 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.
Interventions
DRUGarmodafinil
200 mg/day
DRUGplacebo
placebo
Sponsors
Cephalon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) | Baseline and 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. |
| Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks | Baseline and 8 weeks following start of study drug administration | 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. |
| Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks | baseline and 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 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. |
| Clinical Global Impression of Change (CGI-C) at 4 Weeks | 4 weeks after beginning study drug treatment | 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. |
| Clinical Global Impression of Change (CGI-C) at 8 Weeks | 8 weeks after beginning study drug treatment | 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. |
| Clinical Global Impression of Change (CGI-C) at 12 Weeks | 12 weeks after beginning treatment | 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. |
| Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | 4 weeks after start of treatment | 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. |
| Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | 8 weeks after start of study drug treatment | 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. |
| Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | 12 weeks after starting study drug treatment | 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. |
| Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks | Baseline and 2 weeks following start of study drug administration | 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. |
| Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks | Baseline and 4 weeks after start of study drug administration | 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. |
| Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks | Baseline and 8 weeks after start of study drug administration | 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. |
| Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks | 12 weeks (or last observation after baseline) | 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. |
| Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks | 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. |
| Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks | 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. |
| Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks | 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. |
| Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks | 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. |
| Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score | Baseline and 12 weeks following start of study drug administration or last recorded observation | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks | Baseline and 2 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks | Baseline and 4 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks | Baseline and 8 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks | Baseline and 12 weeks after start of study drug administration | 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. |
| Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | Baseline and 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). |
| Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks | Baseline and 2 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks | Baseline and 4 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks | Baseline and 8 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks | 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. |
| Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | 12 weeks after start of study drug administration (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. |
| Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks | 2 weeks after start of study drug administration | 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. |
| Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks | 4 weeks after start of study drug administration | 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. |
| Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks | 8 weeks after start of study drug administration | 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. |
| Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks | 12 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline) | Baseline and 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks | Baseline and 2 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks | Baseline and 4 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks | Baseline and 8 weeks after start of study drug administration | 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. |
| Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline) | Baseline and 12 weeks after start of study drug administration | 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. |
| Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline) | Baseline and endpoint (12 weeks after start of study drug 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. |
| Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | baseline and 2 weeks following start of study drug administration | 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. |
| Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks | baseline and 4 weeks following start of study drug administration | 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. |
| Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks | baseline and 8 weeks following start of study drug administration | 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. |
| Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks | baseline and 12 weeks following the start of study drug administration | 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. |
| Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) | 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. |
| Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | 2 weeks following start of study drug administration | 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. |
| Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 | 4 weeks following start of study drug administration | 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. |
| Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 | 8 weeks following start of study drug administration | 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. |
| Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 | 12 weeks following the start of study drug administration | 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. |
| Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline) | Baseline and 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). |
| Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks | baseline and 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. |
| Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks | baseline and 4 weeks following start of study drug administration | 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. |
| Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks | baseline and 8 weeks following start of study drug administration | 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. |
| Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline) | Baseline and 12 weeks (or last observation 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. |
| Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline) | Baseline and 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. |
| Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks | Baseline and 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. |
| Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks | Baseline and 4 weeks following start of study drug administration | 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. |
| Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks | baseline and 8 weeks following start of study drug administration | 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. |
| Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks | Baseline and 12 weeks following start of study drug administration | 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. |
| Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks | baseline and 12 weeks following start of study drug administration | 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. |
| Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks | baseline and 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. |
Countries
United States
Participant flow
Recruitment details
55 centers in the US. First participant enrolled: October 2007/ Last participant last visit: March 2009
Pre-assignment details
The study consisted of a 1-week single-blind, placebo run-in screening period followed by a 12-week double blind treatment period. Of the 249 patients enrolled, 248 patients received at least 1 dose of study drug and were evaluated for safety; 1 patient who was assigned to receive armodafinil was lost to follow-up before taking any study drug.
Participants by arm
| Arm | Count |
|---|---|
| Armodafinil 200 mg/Day Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved. | 125 |
| Placebo Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved. | 124 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 7 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Non-Specific | 2 | 1 |
| Overall Study | Physician Decision | 0 | 3 |
| Overall Study | Protocol Violation | 5 | 7 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Placebo | Armodafinil 200 mg/Day | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants | 125 Participants | 249 Participants |
| Age Continuous | 49.5 years STANDARD_DEVIATION 9.69 | 49.5 years STANDARD_DEVIATION 10.32 | 49.5 years STANDARD_DEVIATION 9.99 |
| Region of Enrollment United States | 124 participants | 125 participants | 249 participants |
| Sex: Female, Male Female | 66 Participants | 68 Participants | 134 Participants |
| Sex: Female, Male Male | 58 Participants | 57 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 124 | 34 / 124 |
| serious Total, serious adverse events | 1 / 124 | 3 / 124 |
Outcome results
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.
Time frame: Baseline and 12 weeks (or last observation after baseline)
Population: Full analysis set which includes subjects who had at least 1 measurement of MWT or Clinical Global Impression of Change (CGI-C) after baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) | 2.6 Minutes | Standard Deviation 7.09 |
| Placebo | Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) | 1.1 Minutes | Standard Deviation 7.61 |
Comparison: Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.p-value: 0.3043ANCOVA
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.
Time frame: 12 weeks (or last observation after baseline)
Population: Full analysis set which includes subjects who had at least 1 measurement of MWT or CGI-C after baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) | At least minimal improvement | 78 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) | No improvement | 35 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) | At least minimal improvement | 59 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) | No improvement | 53 Participants |
Comparison: Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.p-value: 0.012Chi-squared
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.
Time frame: Baseline and 12 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks | -2.2 Units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks | -1.3 Units on a scale | Standard Error 0.25 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0126ANCOVA
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.
Time frame: Baseline and 2 weeks
Population: Full analysis set defined as subjects who completed the ES Symptom Rating form at baseline and 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks | -1.6 Units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks | -1.2 Units on a scale | Standard Error 0.22 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1627ANCOVA
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.
Time frame: Baseline and 4 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the ES Symptom Rating Form at Baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks | -2.1 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks | -1.1 Units on a scale | Standard Error 0.23 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0018ANCOVA
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.
Time frame: baseline and 8 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks | -1.8 Units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks | -0.9 Units on a scale | Standard Error 0.25 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0096ANCOVA
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.
Time frame: Baseline and Endpoint (12 weeks or last observation after baseline)
Population: Full analysis set defined as subjects with at least one observation after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline) | -1.8 Units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline) | -1.4 Units on a scale | Standard Error 0.24 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1816ANCOVA
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.
Time frame: Baseline and 12 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed BFI at baseline and at 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline) | -1.1 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline) | -0.3 Units on a scale | Standard Error 0.23 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0129ANCOVA
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.
Time frame: Baseline and 2 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed the BFI at baseline and at 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks | -0.6 Units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks | 0.0 Units on a scale | Standard Error 0.2 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0277ANCOVA
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.
Time frame: Baseline and 4 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed the BFI at baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks | -1.0 Units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks | -0.6 Units on a scale | Standard Error 0.2 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1245ANCOVA
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.
Time frame: Baseline and 8 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed the BFI at baseline and at 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks | -0.9 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks | -0.2 Units on a scale | Standard Error 0.23 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0305ANCOVA
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.
Time frame: Baseline and at endpoint (12 weeks or last observation after baseline)
Population: Full analysis set defined as subjects who had at least one observation after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline) | -0.9 Units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline) | -0.3 Units on a scale | Standard Error 0.22 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0879ANCOVA
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.
Time frame: Baseline and 12 weeks after start of study drug administration
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks | -10.5 Units on a scale | Standard Error 1.92 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks | -3.3 Units on a scale | Standard Error 1.93 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0094ANCOVA
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.
Time frame: Baseline and 2 weeks after start of study drug administration
Population: Full analysis set defined as subjects who had completed BFI at baseline and at 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks | -6.1 Units on a scale | Standard Error 1.67 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks | -0.9 Units on a scale | Standard Error 1.7 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0289ANCOVA
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.
Time frame: Baseline and 4 weeks after start of study drug administration
Population: Full analysis set defined as subjects who had completed BFI at baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks | -9.5 Units on a scale | Standard Error 1.72 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks | -5.8 Units on a scale | Standard Error 1.75 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1272ANCOVA
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.
Time frame: Baseline and 8 weeks after start of study drug administration
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks | -8.8 Units on a scale | Standard Error 1.9 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks | -3.0 Units on a scale | Standard Error 1.97 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0349ANCOVA
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.
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks | -1.4 Units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks | -0.6 Units on a scale | Standard Error 0.26 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0354ANCOVA
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.
Time frame: Baseline and 2 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed BFI at baseline and at 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks | -1.1 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks | -0.2 Units on a scale | Standard Error 0.24 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0105ANCOVA
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.
Time frame: Baseline and 4 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed BFI at baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks | -1.2 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks | -0.8 Units on a scale | Standard Error 0.24 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.2888ANCOVA
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.
Time frame: Baseline and 8 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed the BFI at baseline and at week 8
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks | -1.2 Units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks | -0.3 Units on a scale | Standard Error 0.25 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.013ANCOVA
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.
Time frame: 12 weeks (or last observation after baseline)
Population: Full analysis set defined as subjects who completed ESS at Baseline and at 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks | -6.8 Units on a scale | Standard Error 0.48 |
| Placebo | Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks | -4.8 Units on a scale | Standard Error 0.48 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0025ANCOVA
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.
Time frame: Baseline and 2 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the ESS at baseline and at 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks | -4.8 Unit on a scale | Standard Error 0.4 |
| Placebo | Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks | -3.8 Unit on a scale | Standard Error 0.4 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1072ANCOVA
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.
Time frame: Baseline and 4 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed ESS at baseline and at Week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks | -5.5 Units on a scale | Standard Error 0.42 |
| Placebo | Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks | -4.2 Units on a scale | Standard Error 0.43 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0355ANCOVA
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.
Time frame: Baseline and 8 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed ESS at Baseline and at 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks | -6.0 Units on a scale | Standard Error 0.44 |
| Placebo | Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks | -4.8 Units on a scale | Standard Error 0.45 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0591ANCOVA
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.
Time frame: baseline and 12 weeks following the start of study drug administration
Population: Full analysis set defined as subjects who completed the FOSQ at baseline and at 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks | 2.6 Units on a scale | Standard Error 0.27 |
| Placebo | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks | 1.6 Units on a scale | Standard Error 0.27 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0107ANCOVA
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.
Time frame: baseline and 2 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed FOSQ at baseline and at 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | 1.7 Units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | 1.1 Units on a scale | Standard Error 0.24 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0679ANCOVA
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.
Time frame: baseline and 4 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the FOSQ at baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks | 2.2 Units on a scale | Standard Error 0.23 |
| Placebo | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks | 1.4 Units on a scale | Standard Error 0.22 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0153ANCOVA
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.
Time frame: baseline and 8 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the FOSQ at baseline and at 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks | 2.2 Units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks | 1.4 Units on a scale | Standard Error 0.25 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0296ANCOVA
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.
Time frame: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)
Population: Full analysis set defined as subjects who had at least one observation after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline) | 2.3 Units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline) | 1.5 Units on a scale | Standard Error 0.26 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0308ANCOVA
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.
Time frame: baseline and 12 weeks (or last observation after baseline)
Population: Full analysis set defined as subjects who had measurements of MWT at baseline and 12 weeks.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks | 2.5 Minutes | Standard Error 0.64 |
| Placebo | Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks | 1.4 Minutes | Standard Error 0.64 |
p-value: 0.2196ANCOVA
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.
Time frame: baseline and 4 weeks
Population: Full analysis set defined as subjects who had MWT measurement at baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks | 2.7 Minutes | Standard Error 0.63 |
| Placebo | Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks | -0.1 Minutes | Standard Error 0.64 |
p-value: 0.0019ANCOVA
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.
Time frame: Baseline and 8 weeks following start of study drug administration
Population: Full analysis set defined as subjects with MWT measure at 8 weeks and baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks | 2.1 Minutes | Standard Error 0.61 |
| Placebo | Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks | 1.2 Minutes | Standard Error 0.62 |
p-value: 0.3145ANCOVA
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.
Time frame: baseline and 12 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed MOS-CF6 at baseline and at 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks | 3.3 Units on a scale | Standard Error 0.58 |
| Placebo | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks | 2.4 Units on a scale | Standard Error 0.59 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.2428ANCOVA
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.
Time frame: baseline and 2 weeks
Population: Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks | 2.0 Units on a scale | Standard Error 0.57 |
| Placebo | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks | 1.9 Units on a scale | Standard Error 0.58 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.893ANCOVA
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.
Time frame: baseline and 4 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks | 3.4 Units on a scale | Standard Error 0.5 |
| Placebo | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks | 2.4 Units on a scale | Standard Error 0.51 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1774ANCOVA
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.
Time frame: baseline and 8 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at week 8
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks | 3.3 Units on a scale | Standard Error 0.49 |
| Placebo | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks | 2.1 Units on a scale | Standard Error 0.51 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.1ANCOVA
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).
Time frame: Baseline and Endpoint (12 weeks or last observation after baseline)
Population: Full analysis set defined as subjects who had at least one observation after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline) | 3.2 Units on a scale | Standard Error 0.56 |
| Placebo | Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline) | 2.4 Units on a scale | Standard Error 0.56 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.332ANCOVA
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).
Time frame: Baseline and 12 weeks or last observation after baseline
Population: Full analysis set defined as subjects with at least one observation after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | -1.3 Units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | -0.7 Units on a scale | Standard Error 0.24 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0754ANCOVA
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.
Time frame: Baseline and 12 weeks (or last observation after baseline)
Population: Full analysis set defined as subjects who had at least one assessment of ESS after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline) | -6.5 Units on a scale | Standard Error 0.44 |
| Placebo | Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline) | -4.6 Units on a scale | Standard Error 0.44 |
Comparison: Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.p-value: 0.0027ANCOVA
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.
Time frame: Baseline and 12 weeks following start of study drug administration or last recorded observation
Population: Full analysis set defined as subjects with at least one BFI assessment after baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 200 mg/Day | Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score | -8.9 Units on a scale | Standard Error 1.82 |
| Placebo | Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score | -3.8 Units on a scale | Standard Error 1.84 |
Comparison: Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.p-value: 0.0523ANCOVA
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.
Time frame: 12 weeks after beginning treatment
Population: Full analysis set defined as subjects assessed with CGI-C at week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks | At least minimal improvement | 69 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks | No improvement | 27 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks | At least minimal improvement | 53 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks | No improvement | 42 Participants |
p-value: 0.0207Chi-squared
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.
Time frame: 12 weeks after starting study drug treatment
Population: Full analysis set defined as subjects assessed by CGI-C at 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Minimally improved | 22 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Very much improved | 27 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | No change | 22 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Much improved | 20 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Much worse | 1 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Very much worse | 0 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Minimally worse | 4 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Very much worse | 0 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Very much improved | 11 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Much improved | 22 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | No change | 34 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Much worse | 1 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Minimally worse | 7 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale | Minimally improved | 20 Participants |
p-value: 0.0064Cochran-Mantel-Haenszel
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.
Time frame: 4 weeks after beginning study drug treatment
Population: Full analysis set defined as subjects who were assessed with CGI-C at 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 4 Weeks | At least minimal improvement | 75 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 4 Weeks | No improvement | 36 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 4 Weeks | At least minimal improvement | 64 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 4 Weeks | No improvement | 44 Participants |
p-value: 0.2017Chi-squared
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.
Time frame: 4 weeks after start of treatment
Population: Full analysis set defined as subjects who were assessed by CGI-C at 4 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Minimally worse | 3 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | No change | 32 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Much improved | 34 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Much worse | 1 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Very much improved | 15 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Very much worse | 0 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Minimally improved | 26 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Very much worse | 0 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Very much improved | 11 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Much improved | 21 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Minimally improved | 32 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Minimally worse | 5 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | Much worse | 2 Participants |
| Placebo | Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale | No change | 37 Participants |
p-value: 0.0529Cochran-Mantel-Haenszel
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.
Time frame: 8 weeks after beginning study drug treatment
Population: Full analysis set defined as subjects assessed by CGI-C at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks | At least minimal improvement | 76 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks | No improvement | 28 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks | At least minimal improvement | 52 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks | No improvement | 46 Participants |
p-value: 0.0032Chi-squared
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.
Time frame: 8 weeks after start of study drug treatment
Population: Full analysis set defined as subjects who were assessed by CGI-C at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Much improved | 39 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Minimally worse | 1 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Very much improved | 16 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Much worse | 1 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Minimally improved | 21 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Very much worse | 0 Participants |
| Armodafinil 200 mg/Day | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | No change | 26 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Very much worse | 0 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Minimally improved | 22 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Much improved | 19 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | No change | 37 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Minimally worse | 7 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Much worse | 2 Participants |
| Placebo | Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale | Very much improved | 11 Participants |
p-value: 0.0011Cochran-Mantel-Haenszel
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.
Time frame: 12 weeks after start of study drug administration (or last observation after baseline)
Population: Full analysis set defined as subjects who had at least one observation after baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | Non-responders | 49 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | Responders | 63 Participants |
| Placebo | Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | Responders | 56 Participants |
| Placebo | Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) | Non-responders | 55 Participants |
Comparison: Responders are subjects with worst fatigue score \< 7 after baselinep-value: 0.3854Chi-squared
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.
Time frame: 12 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed the BFI at 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks | Responders | 55 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks | Non-responders | 41 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks | Responders | 48 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks | Non-responders | 47 Participants |
Comparison: Responders are subjects with a worst fatigue score of \< 7p-value: 0.3483Chi-squared
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.
Time frame: 2 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed BFI at 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks | Responders | 62 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks | Non-responders | 48 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks | Responders | 43 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks | Non-responders | 65 Participants |
Comparison: Responders were defined as subjects with worst fatigue score \< 7p-value: 0.0145Chi-squared
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.
Time frame: 4 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed BFI at 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks | Non-responders | 49 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks | Responders | 62 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks | Responders | 57 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks | Non-responders | 51 Participants |
Comparison: Responders were patients with worst fatigue scores \< 7p-value: 0.6475Chi-squared
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.
Time frame: 8 weeks after start of study drug administration
Population: Full analysis set defined as subjects who completed the BFI at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks | Responders | 63 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks | Non-responders | 41 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks | Responders | 42 Participants |
| Placebo | Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks | Non-responders | 56 Participants |
Comparison: Responders are subjects with worst fatigue score \< 7p-value: 0.0118Chi-squared
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.
Time frame: 12 weeks
Population: Full analysis set defined as subjects who completed the ESS at 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks | Non-responders | 31 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks | Responders | 65 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks | Responders | 47 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks | Non-responders | 48 Participants |
p-value: 0.0105Chi-squared
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.
Time frame: 2 weeks
Population: Full analysis set defined as the number of subjects who completed the ESS at 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks | Responders | 54 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks | Non-responders | 53 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks | Responders | 40 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks | Non-responders | 64 Participants |
p-value: 0.0794Chi-squared
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.
Time frame: 4 weeks
Population: Full analysis set defined as number of subjects who completed ESS at 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks | Non-responders | 52 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks | Responders | 59 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks | Responders | 45 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks | Non-responders | 63 Participants |
p-value: 0.0888Chi-squared
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.
Time frame: 8 weeks
Population: Full analysis set defined as subjects who completed ESS at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks | Responders | 64 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks | Non-responders | 39 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks | Responders | 47 Participants |
| Placebo | Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks | Non-responders | 51 Participants |
p-value: 0.0433Chi-squared
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.
Time frame: 12 weeks following the start of study drug administration
Population: Full analysis set defined as subjects who completed the FOSQ at 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 | Responders | 43 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 | Non-responders | 51 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 | Responders | 28 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 | Non-responders | 66 Participants |
Comparison: Responders are defined as subjects with total score \> 17.9p-value: 0.024Chi-squared
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.
Time frame: 4 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the FOSQ at 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 | Responders | 45 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 | Non-responders | 60 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 | Responders | 24 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 | Non-responders | 79 Participants |
Comparison: Responders are defined as subjects with a total score \> 17.9p-value: 0.0027Chi-squared
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.
Time frame: 8 weeks following start of study drug administration
Population: Full analysis set defined as subjects who completed the FOSQ at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 | Non-responders | 65 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 | Responders | 36 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 | Responders | 20 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 | Non-responders | 77 Participants |
Comparison: Responders are defined as subjects who had a total score of \> 17.9p-value: 0.0189Chi-squared
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.
Time frame: 2 weeks following start of study drug administration
Population: Full analysis set defined as subject who completed the FOSQ at 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | Responders | 30 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | Non-responders | 75 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | Responders | 19 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks | Non-responders | 84 Participants |
Comparison: Responders are defined as subjects with a total score of \> 17.9p-value: 0.0854Chi-squared
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.
Time frame: Endpoint (week 12 or last observation after baseline)
Population: Full analysis set defined as subjects with at least one observation after baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) | Non-responders | 61 Participants |
| Armodafinil 200 mg/Day | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) | Responders | 49 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) | Responders | 30 Participants |
| Placebo | Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) | Non-responders | 78 Participants |
Comparison: Responders are defined as patients with a total score on FOSQ \> 17.9p-value: 0.01Chi-squared