Excessive Sleepiness
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
Interventions
DRUGarmodafinil
50 mg/day orally, once daily in the morning for 3 days
DRUGplacebo
placebo tablets, once daily in the morning for 3 days
Sponsors
Cephalon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * History of jet lag symptoms during the past 5 years. * The subject is in good health, as determined by a medical and psychiatric history, medical examination, clinical laboratory test results, and electrocardiography (ECG) and physical examination findings. * Women of childbearing potential must be abstinent or use a medically accepted method of contraception, and must continue use of this method for the duration of the study (and for 30 days after participation in the study). * The subject is willing to comply with study restrictions and remain at the study center overnight, as required. * The subject must agree to refrain from alcohol use during the study. * The subject has a valid U.S. passport Key
Exclusion criteria
* The subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), or any other sleep disorder associated with excessive daytime sleepiness; or the subject has a history or current diagnosis of hypersomnia, insomnia, or sleep disorder. * The subject has any serious acute or chronic cardiovascular, pulmonary, gastrointestinal, neurological, endocrine or renal illness (including diabetes mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant significant medical condition. * The subject has a history of any cutaneous drug reaction or drug hypersensitivity, or any clinically significant hypersensitivity reaction, or multiple allergies. * The subject has a history of deep vein thrombosis (DVT). * The subject has known human immunodeficiency virus (HIV). * The subject is pregnant or lactating. * The subject has used nicotine within the last 3 months. * The subject has a history of seizures, except for a single febrile seizure. * The subject has a psychiatric disorder that would affect participation in the study or full compliance with study procedures. * The subject has a clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings. * The subject used any prescription or over the counter drugs disallowed by the protocol within 7 days of screening visit 2 (i.e., stimulants, hypnotics). * The subject has used an investigational drug within 1 month before the screening visit. * The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion. * The subject has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 | Days 1 and 2 | MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep. |
| Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2 | Days 1 and 2 | The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2 | Day 2 | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here. |
| Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3 | Day 3 | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here. |
| Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline | Baseline prior to starting study medication | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here. |
| Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1 | Day 1 bedtime | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here. |
| Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2 | Day 2 bedtime | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here. |
| Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3 | Day 3 bedtime | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here. |
| Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline | Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1 | MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here. |
| Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1 | Day 1 | MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here. |
| Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2 | Day 2 | MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here. |
| Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3 | Day 3 | MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here. |
| Mean Patient Global Impression of Severity of General Condition Ratings at Baseline | Baseline, prior to start of study drug dosing | The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here. |
| Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS) | Days 1 and 2 | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here. |
| Mean Patient Global Impression of Severity of General Condition Ratings at Day 2 | Day 2 | The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here. |
| Mean Patient Global Impression of Severity of General Condition Ratings at Day 3 | Day 3 | The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here. |
| Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1 | Day 1 | The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here. |
| Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint | Endpoint defined as either Day 3 or last observation after baseline | The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here. |
| Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2 | Day 2 | The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here. |
| Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3 | Day 3 | The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here. |
| Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography | Baseline and Day 2 (Endpoint) | Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography. |
| Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography | Baseline and Day 2 (Endpoint) | Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography. |
| Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography | Baseline and Day 2 (Endpoint) | Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed. |
| Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography | Baseline and Day 2 (Endpoint) | Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography. |
| Mean Patient Global Impression of Severity of General Condition Ratings at Day 1 | Day 1 | The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here. |
| Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1 | Day 1 | The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here. |
Countries
United States
Participant flow
Recruitment details
4 centers in the United States (US; origination study centers) and 3 centers in France (destination study centers). First participant enrolled: September 2008 / Last participant last visit: February 2009
Pre-assignment details
Study consisted of a 1 to 8 week screening period, a 3-day double blind treatment period, and a 7-day follow-up period. 1298 subjects were screened, 431 subjects met entry criteria in the US; 4 subjects were ineligible upon arrival in France (due to AEs), and 1 subject randomized to placebo did not have any post-baseline efficacy assessments.
Participants by arm
| Arm | Count |
|---|---|
| Armodafinil 50 mg/Day Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3. | 142 |
| Armodafinil 150 mg/Day Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3. | 143 |
| Placebo Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3. | 142 |
| Total | 427 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 3 |
| Overall Study | Noncompliance to study procedures | 0 | 0 | 1 |
| Overall Study | Subject legally detained out of state | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Armodafinil 150 mg/Day | Placebo | Armodafinil 50 mg/Day | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 143 Participants | 142 Participants | 142 Participants | 427 Participants |
| Age Continuous | 34.6 years STANDARD_DEVIATION 10.38 | 36.0 years STANDARD_DEVIATION 10.06 | 36.7 years STANDARD_DEVIATION 12.01 | 35.8 years STANDARD_DEVIATION 10.86 |
| Region of Enrollment United States | 143 participants | 142 participants | 142 participants | 427 participants |
| Sex: Female, Male Female | 84 Participants | 67 Participants | 78 Participants | 229 Participants |
| Sex: Female, Male Male | 59 Participants | 75 Participants | 64 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 44 / 142 | 67 / 143 | 41 / 142 |
| serious Total, serious adverse events | 0 / 142 | 0 / 143 | 0 / 142 |
Outcome results
Primary
Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2
The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here.
Time frame: Days 1 and 2
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2 | 1.9 Units on a scale | Standard Error 0.08 |
| Armodafinil 150 mg/Day | Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2 | 1.6 Units on a scale | Standard Error 0.08 |
| Placebo | Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2 | 1.9 Units on a scale | Standard Error 0.08 |
p-value: 0.834195% CI: [-0.2, 0.25]ANOVA
p-value: 0.044195% CI: [-0.5, -0.05]ANCOVA
Primary
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2
MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.
Time frame: Days 1 and 2
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 | 7.7 Minutes | Standard Error 0.29 |
| Armodafinil 150 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 | 11.7 Minutes | Standard Error 0.29 |
| Placebo | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 | 4.8 Minutes | Standard Error 0.29 |
p-value: <0.000195% CI: [2.07, 3.71]ANCOVA
p-value: <0.000195% CI: [6.06, 7.69]ANCOVA
Secondary
Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here.
Time frame: Days 1 and 2
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS) | 4.8 Units on a scale | Standard Error 0.12 |
| Armodafinil 150 mg/Day | Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS) | 4.3 Units on a scale | Standard Error 0.12 |
| Placebo | Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS) | 5.5 Units on a scale | Standard Error 0.12 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.
Time frame: Day 1
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1 | 3.8 Units on a scale | Standard Deviation 6.8 |
| Armodafinil 150 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1 | 4.3 Units on a scale | Standard Deviation 8.24 |
| Placebo | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1 | 4.3 Units on a scale | Standard Deviation 7.04 |
Secondary
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.
Time frame: Day 2
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2 | 1.5 Units on a scale | Standard Deviation 5.82 |
| Armodafinil 150 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2 | 2.8 Units on a scale | Standard Deviation 7.52 |
| Placebo | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2 | 1.3 Units on a scale | Standard Deviation 6.86 |
Secondary
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.
Time frame: Day 3
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3 | -0.1 Units on a scale | Standard Deviation 5.11 |
| Armodafinil 150 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3 | 1.6 Units on a scale | Standard Deviation 8.34 |
| Placebo | Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3 | 0.2 Units on a scale | Standard Deviation 6.6 |
Secondary
Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.
Time frame: Endpoint defined as either Day 3 or last observation after baseline
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and one State and Trait Anxiety Inventory Assessment after Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint | 0.0 Units on a scale | Standard Deviation 5.1 |
| Armodafinil 150 mg/Day | Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint | 1.6 Units on a scale | Standard Deviation 8.3 |
| Placebo | Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint | 0.6 Units on a scale | Standard Deviation 7 |
Secondary
Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.
Time frame: Baseline and Day 2 (Endpoint)
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography | -12.9 Minutes | Standard Deviation 36 |
| Armodafinil 150 mg/Day | Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography | -0.8 Minutes | Standard Deviation 44.78 |
| Placebo | Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography | -11.0 Minutes | Standard Deviation 29.56 |
Secondary
Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.
Time frame: Baseline and Day 2 (Endpoint)
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography | -10.0 Minutes | Standard Deviation 69.76 |
| Armodafinil 150 mg/Day | Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography | -30.5 Minutes | Standard Deviation 83.03 |
| Placebo | Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography | -5.2 Minutes | Standard Deviation 62.88 |
Secondary
Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.
Time frame: Baseline and Day 2 (Endpoint)
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography | 20.0 Minutes | Standard Deviation 70.8 |
| Armodafinil 150 mg/Day | Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography | 30.4 Minutes | Standard Deviation 76.4 |
| Placebo | Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography | 14.4 Minutes | Standard Deviation 62.18 |
Secondary
Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.
Time frame: Baseline and Day 2 (Endpoint)
Population: Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography | -2.1 Percent | Standard Deviation 14.53 |
| Armodafinil 150 mg/Day | Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography | -6.3 Percent | Standard Deviation 17.23 |
| Placebo | Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography | -1.1 Percent | Standard Deviation 13.1 |
Secondary
Mean Patient Global Impression of Severity of General Condition Ratings at Baseline
The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here.
Time frame: Baseline, prior to start of study drug dosing
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had a baseline efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Baseline | 1.0 Units on a scale | Standard Deviation 0.08 |
| Armodafinil 150 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Baseline | 1.0 Units on a scale | Standard Deviation 0.14 |
| Placebo | Mean Patient Global Impression of Severity of General Condition Ratings at Baseline | 1.0 Units on a scale | Standard Deviation 0.19 |
Secondary
Mean Patient Global Impression of Severity of General Condition Ratings at Day 1
The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here.
Time frame: Day 1
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Day 1 | 2.2 units on a scale | Standard Error 0.11 |
| Armodafinil 150 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Day 1 | 1.7 units on a scale | Standard Error 0.11 |
| Placebo | Mean Patient Global Impression of Severity of General Condition Ratings at Day 1 | 2.1 units on a scale | Standard Error 0.11 |
p-value: 0.8262ANOVA
p-value: 0.004ANOVA
Secondary
Mean Patient Global Impression of Severity of General Condition Ratings at Day 2
The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here.
Time frame: Day 2
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Day 2 | 1.6 units on a scale | Standard Error 0.08 |
| Armodafinil 150 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Day 2 | 1.5 units on a scale | Standard Error 0.08 |
| Placebo | Mean Patient Global Impression of Severity of General Condition Ratings at Day 2 | 1.6 units on a scale | Standard Error 0.08 |
p-value: 0.9595ANOVA
p-value: 0.3539ANOVA
Secondary
Mean Patient Global Impression of Severity of General Condition Ratings at Day 3
The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here.
Time frame: Day 3
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Day 3 | 1.2 units on a scale | Standard Error 0.06 |
| Armodafinil 150 mg/Day | Mean Patient Global Impression of Severity of General Condition Ratings at Day 3 | 1.4 units on a scale | Standard Error 0.06 |
| Placebo | Mean Patient Global Impression of Severity of General Condition Ratings at Day 3 | 1.4 units on a scale | Standard Error 0.06 |
p-value: 0.1038ANOVA
p-value: 0.8112ANOVA
Secondary
Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline
MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.
Time frame: Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline | 15.2 Minutes | Standard Deviation 3.82 |
| Armodafinil 150 mg/Day | Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline | 15.3 Minutes | Standard Deviation 3.83 |
| Placebo | Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline | 15.0 Minutes | Standard Deviation 4.17 |
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here.
Time frame: Day 1
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1 | 5.7 Units on a scale | Standard Error 0.14 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1 | 4.8 Units on a scale | Standard Error 0.14 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1 | 6.3 Units on a scale | Standard Error 0.14 |
p-value: 0.0012ANCOVA
p-value: <0.0001ANCOVA
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here.
Time frame: Day 2
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2 | 4.0 Units on a scale | Standard Error 0.12 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2 | 3.8 Units on a scale | Standard Error 0.12 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2 | 4.7 Units on a scale | Standard Error 0.12 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here.
Time frame: Day 3
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3 | 3.6 Units on a scale | Standard Error 0.1 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3 | 3.6 Units on a scale | Standard Error 0.1 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3 | 4.0 Units on a scale | Standard Error 0.1 |
p-value: 0.0022ANCOVA
p-value: 0.0033ANCOVA
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here.
Time frame: Baseline prior to starting study medication
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline | 4.0 Units on a scale | Standard Deviation 1.71 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline | 4.0 Units on a scale | Standard Deviation 1.84 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline | 3.8 Units on a scale | Standard Deviation 1.76 |
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here.
Time frame: Day 1 bedtime
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1 | 7.2 Units on a scale | Standard Deviation 1.97 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1 | 6.9 Units on a scale | Standard Deviation 2.05 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1 | 7.1 Units on a scale | Standard Deviation 2.19 |
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here.
Time frame: Day 2 bedtime
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2 | 5.2 Units on a scale | Standard Deviation 1.96 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2 | 5.2 Units on a scale | Standard Deviation 2.01 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2 | 5.0 Units on a scale | Standard Deviation 2.13 |
Secondary
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep). The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here.
Time frame: Day 3 bedtime
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3 | 3.6 Units on a scale | Standard Deviation 1.71 |
| Armodafinil 150 mg/Day | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3 | 3.9 Units on a scale | Standard Deviation 1.88 |
| Placebo | Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3 | 3.5 Units on a scale | Standard Deviation 1.9 |
Secondary
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1
MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.
Time frame: Day 1
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1 | 5.6 Minutes | Standard Error 0.32 |
| Armodafinil 150 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1 | 9.6 Minutes | Standard Error 0.32 |
| Placebo | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1 | 3.4 Minutes | Standard Error 0.32 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2
MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.
Time frame: Day 2
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2 | 9.9 Minutes | Standard Error 0.36 |
| Armodafinil 150 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2 | 13.8 Minutes | Standard Error 0.36 |
| Placebo | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2 | 6.2 Minutes | Standard Error 0.36 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3
MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.
Time frame: Day 3
Population: Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil 50 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3 | 12.1 Minutes | Standard Error 0.38 |
| Armodafinil 150 mg/Day | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3 | 14.8 Minutes | Standard Error 0.38 |
| Placebo | Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3 | 8.3 Minutes | Standard Error 0.39 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA