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Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

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ClinicalTrials.gov Identifier: NCT01080807
Recruitment Status : Completed
First Posted : March 4, 2010
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Excessive Sleepiness
Interventions Drug: Armodafinil
Drug: Matching Placebo
Enrollment 385
Recruitment Details 385 patients at 45 centers in the US met entry criteria and were considered eligible for enrollment into the study; 2 of these patients enrolled twice under different identification numbers. Of the 383 patients enrolled, 371 received at least 1 dose of study drug and were evaluated for safety; 12 patients withdrew before taking any study drug.
Pre-assignment Details The study consisted of a 1- to 3-week screening period, a 1-week baseline period (followed by randomization), and a 6-week double-blind treatment period.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule. At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Period Title: Overall Study
Started 193 [1] 190 [2]
Completed 158 167
Not Completed 35 23
Reason Not Completed
Adverse Event             9             1
Lack of Efficacy             0             1
Withdrawal by Subject             7             2
Protocol Violation             7             6
Lost to Follow-up             6             4
Noncompliance with drug administration             1             1
Noncompliance to study procedures             1             1
Began working day shift             0             2
Laid off or terminated from job             1             2
Stopped working consistent night shifts             0             1
Work schedule changing             1             1
Work schedule and travel             0             1
Switched to first shift             1             0
Moved away without notifying center             1             0
[1]
Nine patients randomly assigned to the armodafinil treatment group did not receive study drug.
[2]
Three patients randomly assigned to the placebo treatment group did not receive study drug.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo Total
Hide Arm/Group Description At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule. At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule. Total of all reporting groups
Overall Number of Baseline Participants 193 190 383
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 190 participants 383 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
193
 100.0%
190
 100.0%
383
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 190 participants 383 participants
36.7  (10.71) 36.1  (10.75) 36.4  (10.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 190 participants 383 participants
Female
85
  44.0%
90
  47.4%
175
  45.7%
Male
108
  56.0%
100
  52.6%
208
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 193 participants 190 participants 383 participants
193 190 383
1.Primary Outcome
Title Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint
Hide Description The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 177 182
Measure Type: Number
Unit of Measure: Percentage of participants
77 57
2.Secondary Outcome
Title Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score
Hide Description The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 177 182
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.4  (0.62) 5.0  (0.64)
3.Secondary Outcome
Title Change From Baseline to Week 3 in Global Assessment of Functioning
Hide Description The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.
Time Frame Baseline and Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 168 175
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.9  (0.51) 3.7  (0.52)
4.Secondary Outcome
Title Change From Baseline to Week 6 in Global Assessment of Functioning
Hide Description The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 157 167
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.8  (0.66) 4.9  (0.67)
5.Secondary Outcome
Title Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score
Hide Description The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 176 180
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.8  (0.16) -1.8  (0.17)
6.Secondary Outcome
Title Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score
Hide Description The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.
Time Frame Baseline and week 3
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 166 171
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.6  (0.16) -1.6  (0.16)
7.Secondary Outcome
Title Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score
Hide Description The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed represents the number of participants with evaluable data.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 157 167
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.9  (0.17) -1.8  (0.17)
8.Secondary Outcome
Title Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3
Hide Description The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
Time Frame Baseline and week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 3
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 168 175
Measure Type: Number
Unit of Measure: Percentage of participants
78 51
9.Secondary Outcome
Title Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6
Hide Description The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 6
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 157 167
Measure Type: Number
Unit of Measure: Percentage of participants
80 56
10.Secondary Outcome
Title Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score
Hide Description Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 176 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-6.6  (0.6) -4.2  (0.62)
11.Secondary Outcome
Title Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score
Hide Description Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 176 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.2  (0.24) -1.2  (0.25)
12.Secondary Outcome
Title Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score
Hide Description Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Time Frame Baseline and week 6 (or last observation (or last observation after baseline))
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 176 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.2  (0.23) -1.5  (0.24)
13.Secondary Outcome
Title Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score
Hide Description Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 176 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.2  (0.23) -1.5  (0.23)
14.Secondary Outcome
Title Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities
Hide Description Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 177 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.5  (0.10) -0.4  (0.10)
15.Secondary Outcome
Title Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity
Hide Description Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 177 181
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.4  (0.13) -0.7  (0.14)
16.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint
Hide Description TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.
Time Frame Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 119 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
65.7  (2.46) 46.1  (2.48)
17.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint
Hide Description TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.
Time Frame Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 119 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
88.3  (1.62) 96.3  (1.63)
18.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint
Hide Description TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.
Time Frame Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 119 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
82.5  (1.50) 80.7  (1.51)
19.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint
Hide Description TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.
Time Frame Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 119 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
59.9  (2.72) 44.1  (2.74)
20.Secondary Outcome
Title Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
Hide Description FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 174 177
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.3  (0.3) 2.6  (0.32)
21.Secondary Outcome
Title Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score
Hide Description FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 174 177
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.7  (0.07) 0.5  (0.07)
22.Secondary Outcome
Title Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score
Hide Description FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 175 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.7  (0.07) 0.6  (0.08)
23.Secondary Outcome
Title Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score
Hide Description FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 174 178
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.7  (0.07) 0.5  (0.08)
24.Secondary Outcome
Title Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome
Hide Description FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 169 173
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.6  (0.09) 0.5  (0.09)
25.Secondary Outcome
Title Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy
Hide Description FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).
Time Frame Baseline and week 6 (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description:
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Overall Number of Participants Analyzed 152 148
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.6  (0.08) 0.5  (0.08)
Time Frame Adverse events were recorded throughout the study, from screening through Week 6 (or early termination visit).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule. At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
All-Cause Mortality
150 mg/Day Armodafinil Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
150 mg/Day Armodafinil Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/184 (0.00%)   1/187 (0.53%) 
Renal and urinary disorders     
Nephrolithiasis *  0/184 (0.00%)  1/187 (0.53%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
150 mg/Day Armodafinil Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   55/184 (29.89%)   22/187 (11.76%) 
Gastrointestinal disorders     
Dry mouth *  8/184 (4.35%)  3/187 (1.60%) 
Nausea *  20/184 (10.87%)  7/187 (3.74%) 
Nervous system disorders     
Headache *  28/184 (15.22%)  13/187 (6.95%) 
Psychiatric disorders     
Insomnia *  12/184 (6.52%)  3/187 (1.60%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Vice President, Medical Affairs
Organization: Cephalon, Inc.
Phone: 610-727-6353
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Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01080807     History of Changes
Other Study ID Numbers: C10953/4030
First Submitted: March 3, 2010
First Posted: March 4, 2010
Results First Submitted: October 21, 2011
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012