Trial Outcomes & Findings for Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder (NCT NCT00758498)

NCT ID: NCT00758498

Last Updated: 2013-07-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 427 participants
• Primary outcome timeframe: Days 1 and 2
• Results posted on: 2013-07-19

Participant Flow

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

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.

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	142	143	142
Overall Study COMPLETED	139	141	137
Overall Study NOT COMPLETED	3	2	5

Reasons for withdrawal

Measure	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.	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.	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.
Overall Study Adverse Event	2	2	3
Overall Study Subject legally detained out of state	1	0	0
Overall Study Withdrawal by Subject	0	0	1
Overall Study Noncompliance to study procedures	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=142 Participants 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.	Total n=427 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	142 Participants n=5 Participants	143 Participants n=7 Participants	142 Participants n=5 Participants	427 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	36.7 years STANDARD_DEVIATION 12.01 • n=5 Participants	34.6 years STANDARD_DEVIATION 10.38 • n=7 Participants	36.0 years STANDARD_DEVIATION 10.06 • n=5 Participants	35.8 years STANDARD_DEVIATION 10.86 • n=4 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	84 Participants n=7 Participants	67 Participants n=5 Participants	229 Participants n=4 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	59 Participants n=7 Participants	75 Participants n=5 Participants	198 Participants n=4 Participants
Region of Enrollment United States	142 participants n=5 Participants	143 participants n=7 Participants	142 participants n=5 Participants	427 participants n=4 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
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	11.7 Minutes Standard Error 0.29	4.8 Minutes Standard Error 0.29

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
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	1.6 Units on a scale Standard Error 0.08	1.9 Units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)	4.8 Units on a scale Standard Error 0.12	4.3 Units on a scale Standard Error 0.12	5.5 Units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1	5.7 Units on a scale Standard Error 0.14	4.8 Units on a scale Standard Error 0.14	6.3 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2	4.0 Units on a scale Standard Error 0.12	3.8 Units on a scale Standard Error 0.12	4.7 Units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=140 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3	3.6 Units on a scale Standard Error 0.10	3.6 Units on a scale Standard Error 0.10	4.0 Units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline	4.0 Units on a scale Standard Deviation 1.71	4.0 Units on a scale Standard Deviation 1.84	3.8 Units on a scale Standard Deviation 1.76

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=140 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1	7.2 Units on a scale Standard Deviation 1.97	6.9 Units on a scale Standard Deviation 2.05	7.1 Units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=139 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2	5.2 Units on a scale Standard Deviation 1.96	5.2 Units on a scale Standard Deviation 2.01	5.0 Units on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=140 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3	3.6 Units on a scale Standard Deviation 1.71	3.9 Units on a scale Standard Deviation 1.88	3.5 Units on a scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline	15.2 Minutes Standard Deviation 3.82	15.3 Minutes Standard Deviation 3.83	15.0 Minutes Standard Deviation 4.17

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1	5.6 Minutes Standard Error 0.32	9.6 Minutes Standard Error 0.32	3.4 Minutes Standard Error 0.32

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2	9.9 Minutes Standard Error 0.36	13.8 Minutes Standard Error 0.36	6.2 Minutes Standard Error 0.36

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=140 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3	12.1 Minutes Standard Error 0.38	14.8 Minutes Standard Error 0.38	8.3 Minutes Standard Error 0.39

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=140 Participants 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.
Mean Patient Global Impression of Severity of General Condition Ratings at Baseline	1.0 Units on a scale Standard Deviation 0.08	1.0 Units on a scale Standard Deviation 0.14	1.0 Units on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Mean Patient Global Impression of Severity of General Condition Ratings at Day 1	2.2 units on a scale Standard Error 0.11	1.7 units on a scale Standard Error 0.11	2.1 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=142 Participants 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.	Placebo n=139 Participants 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.
Mean Patient Global Impression of Severity of General Condition Ratings at Day 2	1.6 units on a scale Standard Error 0.08	1.5 units on a scale Standard Error 0.08	1.6 units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=139 Participants 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.
Mean Patient Global Impression of Severity of General Condition Ratings at Day 3	1.2 units on a scale Standard Error 0.06	1.4 units on a scale Standard Error 0.06	1.4 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=142 Participants 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.	Armodafinil 150 mg/Day n=143 Participants 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.	Placebo n=141 Participants 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.
Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint	0.0 Units on a scale Standard Deviation 5.10	1.6 Units on a scale Standard Deviation 8.30	0.6 Units on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=140 Participants 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.	Placebo n=140 Participants 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.
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1	3.8 Units on a scale Standard Deviation 6.8	4.3 Units on a scale Standard Deviation 8.24	4.3 Units on a scale Standard Deviation 7.04

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=139 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=136 Participants 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.
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2	1.5 Units on a scale Standard Deviation 5.82	2.8 Units on a scale Standard Deviation 7.52	1.3 Units on a scale Standard Deviation 6.86

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=140 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3	-0.1 Units on a scale Standard Deviation 5.11	1.6 Units on a scale Standard Deviation 8.34	0.2 Units on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography	-10.0 Minutes Standard Deviation 69.76	-30.5 Minutes Standard Deviation 83.03	-5.2 Minutes Standard Deviation 62.88

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography	-12.9 Minutes Standard Deviation 36.00	-0.8 Minutes Standard Deviation 44.78	-11.0 Minutes Standard Deviation 29.56

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography	-2.1 Percent Standard Deviation 14.53	-6.3 Percent Standard Deviation 17.23	-1.1 Percent Standard Deviation 13.10

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Armodafinil 50 mg/Day n=141 Participants 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.	Armodafinil 150 mg/Day n=141 Participants 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.	Placebo n=138 Participants 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.
Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography	20.0 Minutes Standard Deviation 70.80	30.4 Minutes Standard Deviation 76.40	14.4 Minutes Standard Deviation 62.18

Adverse Events

Armodafinil 50 mg/Day

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Armodafinil 150 mg/Day

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Armodafinil 50 mg/Day n=142 participants at risk 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.	Armodafinil 150 mg/Day n=143 participants at risk 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.	Placebo n=142 participants at risk 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.
Cardiac disorders Palpitations	0.70% 1/142	4.9% 7/143	0.00% 0/142
Gastrointestinal disorders Nausea	2.8% 4/142	12.6% 18/143	3.5% 5/142
Gastrointestinal disorders Diarrhea	4.2% 6/142	4.9% 7/143	2.8% 4/142
Injury, poisoning and procedural complications Medical device site reaction	16.2% 23/142	16.8% 24/143	17.6% 25/142
Nervous system disorders Headache	16.2% 23/142	25.2% 36/143	11.3% 16/142
Nervous system disorders Dizziness	1.4% 2/142	4.2% 6/143	4.9% 7/142

Additional Information

Medical Monitor

Cephalon, Inc.

Phone: 1-800-896-5855

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60