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Trial record 45 of 239 for:    (armodafinil)

Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

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ClinicalTrials.gov Identifier: NCT00711516
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : February 14, 2011
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Excessive Sleepiness
Interventions Drug: Armodafinil
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Armodafinil (200 mg/Day) Placebo
Hide Arm/Group Description Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period. Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Period Title: Overall Study
Started 21 19
Completed 20 16
Not Completed 1 3
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             0             1
Protocol Violation             0             1
Arm/Group Title Armodafinil (200 mg/Day) Placebo Total
Hide Arm/Group Description Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period. Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
19
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
49.9  (8.98) 50.7  (7.95) 50.3  (8.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
4
  19.0%
5
  26.3%
9
  22.5%
Male
17
  81.0%
14
  73.7%
31
  77.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21 19 40
1.Primary Outcome
Title Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation
Hide Description The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the full analysis dataset which includes those patients in the safety analysis set who had at least 1 post baseline primary efficacy assessment.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Activated voxels
-1932.3  (2993.8) -2428.1  (5023.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7382
Comments The hierarchical testing procedure was employed to control the studywise error rate at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -241.8
Confidence Interval (2-Sided) 95%
-2470.0 to 2102.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed
Hide Description The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds (ms)
2.3  (78.94) -59.0  (112.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1661
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 53.2
Confidence Interval (2-Sided) 95%
-17.8 to 136.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)
Hide Description The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Activated Voxels
-107.3  (367.92) -206.5  (340.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5774
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 78.9
Confidence Interval (2-Sided) 95%
-157.8 to 311.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)
Hide Description The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Activated voxels
-595.0  (1251.79) -773.3  (1693.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8610
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 90.1
Confidence Interval (2-Sided) 95%
-806.7 to 707.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus
Hide Description The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Error)
Unit of Measure: Activated voxels
-841.7  (401.77) -1417.9  (638.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6907
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 252.8
Confidence Interval (2-Sided) 95%
-1066.5 to 1523.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Overall Number of Units Analyzed
Type of Units Analyzed: Trials
24 24
Mean (Standard Deviation)
Unit of Measure: Percent correct trials
-0.1  (6.56) 3.2  (6.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2456
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-8.0 to 0.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another "delayed" recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 19 16
Overall Number of Units Analyzed
Type of Units Analyzed: Trials
24 24
Mean (Standard Deviation)
Unit of Measure: Percent correct trials
0.4  (12.34) -1.1  (10.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7115
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-8.0 to 9.0
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Median (Full Range)
Unit of Measure: Milliseconds (ms)
-6.5
(-54.0 to 47.0)
-12.5
(-252.0 to 44.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6103
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-13.0 to 19.0
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Median (Full Range)
Unit of Measure: Milliseconds (ms)
-13.5
(-45.0 to 37.0)
-4.5
(-224.0 to 39.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9619
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-18.0 to 17.0
Estimation Comments [Not Specified]
10.Secondary Outcome
Title One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds (ms)
-787.9  (1198.06) -666.7  (1751.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4544
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -335.5
Confidence Interval (2-Sided) 95%
-1270.7 to 723.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Milliseconds (ms)
-733.3  (8352.4) -6898.1  (8708.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0193
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 6410.3
Confidence Interval (2-Sided) 95%
1064.7 to 12087.3
Estimation Comments [Not Specified]
12.Secondary Outcome
Title One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy measure after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Choices to correct
0.0  (0.08) 0.0  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1704
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.1 to 0.0
Estimation Comments [Not Specified]
13.Secondary Outcome
Title One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint
Hide Description OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: Choices to correct
-0.2  (0.29) 0.0  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0609
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3 to 0.0
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Epworth Sleepiness Scale Change From Baseline to Endpoint
Hide Description The patient’s evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient’s propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who had at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.8  (1.03) -2.9  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was <= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were <= 0.05. If any were >0.05 subsequent p-values would be reported as nominal p-values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0499
Comments Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-5.8 to -0.0
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint
Hide Description Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient’s condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Participants
13 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7343
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint
Hide Description The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population defined as subjects who had at least one efficacy evaluation after baseline.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.1  (2.82) -0.2  (3.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1246
Comments P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.2
Confidence Interval (2-Sided) 95%
-1.8 to 14.3
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)
Hide Description Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Median (Full Range)
Unit of Measure: Percentage change in BOLD signal
-0.398
(-23.439 to 45.139)
4.704
(-43.840 to 94.919)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7382
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -4.026
Confidence Interval (2-Sided) 95%
-21.684 to 19.980
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)
Hide Description Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Median (Full Range)
Unit of Measure: Percent change in BOLD signal
-1.777
(-38.587 to 99.034)
7.148
(-100.0 to 55.958)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.086
Confidence Interval (2-Sided) 95%
-19.195 to 25.043
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)
Hide Description Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Median (Full Range)
Unit of Measure: Percent change in Bold signal
3.199
(-31.541 to 27.343)
-2.021
(-30.116 to 32.956)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8861
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1.282
Confidence Interval (2-Sided) 95%
-11.460 to 14.770
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus
Hide Description Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Median (Full Range)
Unit of Measure: Percent change in BOLD signal
16.363
(-41.089 to 98.265)
2.099
(-30.301 to 74.962)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4738
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 11.825
Confidence Interval (2-Sided) 95%
-12.601 to 37.987
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint
Hide Description With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.422 -0.445
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0573
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0754
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
22.Secondary Outcome
Title Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint
Hide Description With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.254 -0.152
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2727
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .5671
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments [Not Specified]
23.Secondary Outcome
Title Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint
Hide Description With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.355 -0.358
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1169
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1634
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
24.Secondary Outcome
Title Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint
Hide Description With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.405 -0.038
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0692
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .8876
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
25.Secondary Outcome
Title Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
Hide Description With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
-0.122 0.789
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6030
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
26.Secondary Outcome
Title Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
Hide Description With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.025 -0.012
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9170
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .9642
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
27.Secondary Outcome
Title Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
Hide Description With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.065 0.364
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7813
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1560
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
28.Secondary Outcome
Title Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint
Hide Description With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.
Time Frame Week 2 or Last Observation after Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: Correlation Coefficient
-0.029 0.582
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9010
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.
29.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test
Hide Description This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test defined as subjects who had a response latency of < 713 ms at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 8 4
Mean (Standard Error)
Unit of Measure: Activated voxels
-1411.6  (1365.62) -1359.0  (1146.49)
30.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had response latency < 713 ms) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 8 4
Mean (Standard Error)
Unit of Measure: Voxels
-38.6  (113.68) -227.8  (213.46)
31.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had a response latency < 713 ms) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 8 4
Mean (Standard Error)
Unit of Measure: Voxels
-789.1  (588.22) -397.7  (366.33)
32.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (response latency < 713 ms) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 8 4
Mean (Standard Error)
Unit of Measure: Voxels
-764.7  (626.55) -1446.7  (1091.13)
33.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group analysis among non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: Voxels
-2279.4  (686.69) -2784.4  (1643.79)
34.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: Voxels
-153.1  (116.30) -199.4  (94.97)
35.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: Voxels
-465.5  (273.77) -898.5  (554.98)
36.Secondary Outcome
Title Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test
Hide Description This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: Voxels
-893.1  (545.48) -1408.3  (795.57)
37.Secondary Outcome
Title Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC).
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: BOLD signal intensity
5.556
(-40.0 to 971.429)
3.755
(-39.855 to 33.333)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7053
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 4.841
Confidence Interval (2-Sided) 95%
-27.778 to 19.313
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC).
Time Frame Baseline and Endpoint (Week 2 or last observation after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one observation after baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: BOLD signal intensity
2.778
(-100.0 to 85.714)
0.0
(-45.714 to 75.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5163
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 4.792
Confidence Interval (2-Sided) 95%
-30.631 to 16.190
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC).
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who have had at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: BOLD signal intensity
2.667
(-25.0 to 144.444)
2.479
(-32.283 to 18.831)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8711
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.108
Confidence Interval (2-Sided) 95%
-14.341 to 5.498
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus.
Time Frame Baseline and Endpoint (Week 2 or last observation after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who have had at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: BOLD signal intensity
5.128
(-30.769 to 544.444)
1.429
(-29.204 to 22.222)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1825
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 13.855
Confidence Interval 95%
-15.357 to 25.714
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: Voxels
941.5
(-12443.0 to 11600.0)
-174.5
(-9388.5 to 12014.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9282
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -323.5
Confidence Interval (2-Sided) 95%
-9311.0 to 2375.5
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC).
Time Frame Baseline and Endpoint (Week 2 or last observation after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: Voxels
-27.5
(-1969.0 to 1229.5)
-54.0
(-883.0 to 2750.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-1069.0 to 426.0
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC).
Time Frame Baseline and Endpoint (Week 2 or last observation after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: Voxels
22.0
(-4602.0 to 759.0)
104.3
(-1994.5 to 1747.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5284
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -82.8
Confidence Interval (2-Sided) 95%
-788.0 to 165.5
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State
Hide Description At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus.
Time Frame Baseline and Endpoint (Week 2 or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects with at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 17 16
Median (Full Range)
Unit of Measure: Voxels
-621.0
(-5251.0 to 3171.5)
-883.8
(-5876.0 to 5806.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8997
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -145.8
Confidence Interval (2-Sided) 95%
-3151.0 to 1006.5
Estimation Comments [Not Specified]
45.Secondary Outcome
Title Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test
Hide Description During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (“Psychomotor Vigilance Test [PVT]-like task,” nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner—in this instance, the “+” symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented.
Time Frame Baseline and Endpoint (Week 2 or last observation after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as subjects who had at least one observation after Baseline
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
Overall Number of Participants Analyzed 15 15
Least Squares Mean (Standard Error)
Unit of Measure: milliseconds (ms)
-31.9  (13.41) -6.8  (13.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1305
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -25.1
Confidence Interval (2-Sided) 95%
-58.2 to 8.0
Estimation Comments [Not Specified]
Time Frame 2 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil (200 mg/Day) Placebo
Hide Arm/Group Description Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period. Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
All-Cause Mortality
Armodafinil (200 mg/Day) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil (200 mg/Day) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil (200 mg/Day) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/21 (61.90%)   3/19 (15.79%) 
Cardiac disorders     
Angina pectoris  1  1/21 (4.76%)  0/19 (0.00%) 
Tachycardia  1  1/21 (4.76%)  0/19 (0.00%) 
Eye disorders     
Visual impairment  1  0/21 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders     
Abdominal Pain upper  1  1/21 (4.76%)  0/19 (0.00%) 
Diarrhea  1  2/21 (9.52%)  0/19 (0.00%) 
Nausea  1  1/21 (4.76%)  0/19 (0.00%) 
General disorders     
Chest discomfort  1  1/21 (4.76%)  0/19 (0.00%) 
Energy increased  1  1/21 (4.76%)  0/19 (0.00%) 
Irritability  1  1/21 (4.76%)  0/19 (0.00%) 
Immune system disorders     
Seasonal allergy  1  1/21 (4.76%)  0/19 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  3/21 (14.29%)  0/19 (0.00%) 
Upper respiratory tract infection  1  1/21 (4.76%)  0/19 (0.00%) 
Investigations     
Cardiac murmur  1  1/21 (4.76%)  0/19 (0.00%) 
Heart rate increased  1  1/21 (4.76%)  0/19 (0.00%) 
Nervous system disorders     
Dizziness  1  0/21 (0.00%)  1/19 (5.26%) 
Headache  1  4/21 (19.05%)  1/19 (5.26%) 
Hypoaesthesia  1  1/21 (4.76%)  0/19 (0.00%) 
Sensory disturbance  1  0/21 (0.00%)  1/19 (5.26%) 
Psychiatric disorders     
Anxiety  1  0/21 (0.00%)  1/19 (5.26%) 
Bruxism  1  1/21 (4.76%)  0/19 (0.00%) 
Renal and urinary disorders     
Pollakuria  1  1/21 (4.76%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/21 (4.76%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  0/21 (0.00%)  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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
Name/Title: Sponsor's Medical Expert, Clinical Research
Organization: Cephalon, Inc.
Phone: 1-800-896-5855
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00711516     History of Changes
Other Study ID Numbers: C10953/4026/AP/US
First Submitted: July 8, 2008
First Posted: July 9, 2008
Results First Submitted: September 30, 2010
Results First Posted: February 14, 2011
Last Update Posted: July 19, 2013