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Trial record 72 of 240 for:    (armodafinil)

Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00893789
Recruitment Status : Terminated (Study has been stopped by sponsor decision.)
First Posted : May 6, 2009
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Interventions Drug: Armodafinil
Other: Placebo
Enrollment 117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description Oral placebo tablets, once daily (QD) Oral armodafinil 50 mg tablets, once daily (QD) Oral armodafinil 150 mg tablets, once daily (QD) Oral armodafinil 250 mg tablets, once daily (QD)
Period Title: Overall Study
Started 29 30 29 29
Safety Analysis Set (SAS) 29 [1] 30 29 29
Full Analysis Set (FAS) 29 [2] 29 28 27
Completed 23 26 22 16
Not Completed 6 4 7 13
Reason Not Completed
Withdrawal by Subject             3             1             3             1
Noncompliance With Study Drug             1             0             1             2
Noncompliance With Study Procedures             1             0             0             0
Taking Excluded Concomitant Medication             1             0             1             0
Adverse Event             0             2             1             5
Protocol Violation             0             1             1             4
Lost to Follow-up             0             0             0             1
[1]
SAS = all participants who received 1 or more doses of study drug.
[2]
FAS = participants in the safety analysis set with ≥1 postbaseline primary efficacy assessment.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day Total
Hide Arm/Group Description Oral placebo tablets, once daily (QD) Oral armodafinil 50 mg tablets, once daily (QD) Oral armodafinil 150 mg tablets, once daily (QD) Oral armodafinil 250 mg tablets, once daily (QD) Total of all reporting groups
Overall Number of Baseline Participants 29 30 29 29 117
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 29 participants 29 participants 117 participants
30.2  (11.02) 33.2  (9.31) 32.3  (10.81) 29.4  (11.07) 31.3  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 29 participants 29 participants 117 participants
Female
14
  48.3%
13
  43.3%
13
  44.8%
13
  44.8%
53
  45.3%
Male
15
  51.7%
17
  56.7%
16
  55.2%
16
  55.2%
64
  54.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 29 participants 29 participants 117 participants
American Indian or Alaska Native 0 0 1 0 1
Asian 1 0 0 1 2
Black or African American 2 2 6 4 14
White 26 27 22 24 99
More than one race 0 1 0 0 1
1.Primary Outcome
Title Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)
Hide Description The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. If a participant did not fall asleep in 20 minutes, his/her sleep latency for that nap was set to 20 minutes. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.
Time Frame Baseline, last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with measurements at given time point.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 29 28 27
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline (BL; n=29, 29, 28, 27) 3.3  (1.79) 4.2  (1.69) 4.2  (2.05) 3.7  (2.04)
Change from BL at Endpoint (n=27, 29, 26, 21) 2.4  (4.03) 2.6  (4.35) 5.0  (4.95) 7.2  (6.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 50 mg/Day
Comments P-value for “Change from Baseline at Endpoint.”
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8336
Comments The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 150 mg/Day
Comments P-value for “Change from Baseline at Endpoint.”
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0514
Comments The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 250 mg/Day
Comments P-value for “Change from Baseline at Endpoint.”
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)
Hide Description The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses 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 were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.
Time Frame Last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment).
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 29 28 27
Measure Type: Number
Unit of Measure: percentage of participants
Responders 38 41 54 48
Nonresponders 62 59 46 52
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 50 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7884
Comments [Not Specified]
Method Pearson's chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2359
Comments [Not Specified]
Method Pearson's chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 250 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4401
Comments [Not Specified]
Method Pearson's chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12
Hide Description The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.
Time Frame Baseline, Weeks 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time points.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 29 28 27
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline (BL; n=29, 29, 28, 27) 3.3  (1.79) 4.2  (1.69) 4.2  (2.05) 3.7  (2.04)
Change from BL at Week 4 (n=26, 29, 26, 20) 3.2  (4.93) 2.7  (5.21) 4.0  (5.43) 7.0  (4.80)
Change from BL at Week 8 (n=24, 27, 24, 17) 2.1  (4.73) 2.5  (4.88) 4.2  (5.94) 4.2  (5.47)
Change from BL at Week 12 (n=22, 26, 22, 15) 1.8  (3.87) 2.7  (4.53) 4.6  (4.39) 7.4  (6.38)
4.Secondary Outcome
Title Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Hide Description The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses 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 were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.
Time Frame Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with a nonmissing value at given time point.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 29 28 27
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Responders (n=28, 29, 27, 23) 14 21 37 39
Week 2 Nonresponders (n=28, 29, 27, 23) 86 79 63 61
Week 4 Responders (n=27, 29, 26, 20) 22 24 50 50
Week 4 Nonresponders (n=27, 29, 26, 20) 78 76 50 50
Week 8 Responders (n=23, 27, 24, 18) 35 48 54 56
Week 8 Nonresponders (n=23, 27, 24, 18) 65 52 46 44
Week 12 Responders (n=23, 26, 22, 16) 35 42 55 56
Week 12 Nonresponders (n=23, 26, 22, 16) 65 58 45 44
5.Secondary Outcome
Title Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
Hide Description The TBI-WIS is a validated participant-rated instrument for assessing a participant’s functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a “true” or “not true” answer. To score the questionnaire, the number of “true” responses is counted: if < 2, the risk is low; 2 to 23, the risk is medium; and >23, the risk is high, for work instability. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability).
Time Frame Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set (participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment) with a baseline TBI-WIS measurement; n=number of participants with values at given time points.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 24 24 19 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=24, 24, 19, 21) 8.5  (6.75) 9.3  (8.80) 8.7  (7.55) 11.6  (10.71)
Change from BL at Week 4 (n=23, 23, 18, 15) -2.5  (4.71) -2.5  (3.72) -0.5  (3.71) -2.8  (3.88)
Change from BL at Week 8 (n=19, 22, 17, 13) -1.4  (5.52) -3.5  (4.94) -2.4  (5.26) -4.7  (8.89)
Change from BL at Week 12 (n=19, 21, 17, 12) -0.9  (6.27) -3.9  (4.74) -2.5  (4.32) -5.0  (6.90)
Change from BL at Endpoint (n=24, 24, 19, 19) -2.3  (6.44) -3.4  (4.60) -2.5  (4.07) -2.5  (7.12)
6.Secondary Outcome
Title Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
Hide Description The patient’s evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient’s propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered.
Time Frame Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time point.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 29 28 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=29, 29, 28, 27) 14.8  (2.83) 14.3  (2.61) 15.1  (2.54) 16.1  (3.82)
Change from BL at Week 12 (n=23, 26, 22, 16) -5.0  (6.12) -4.6  (5.30) -6.5  (4.40) -9.2  (4.90)
Change from BL at Endpoint (n=27, 28, 26, 23) -5.1  (5.93) -4.5  (5.15) -6.1  (4.52) -7.0  (5.61)
7.Secondary Outcome
Title Percentage of Participants Answering "No" to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
Hide Description The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). The number of participants answering 'no' to all 9 yes/no questions about suicidal behaviors, ideations, and acts are presented. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.
Time Frame Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (all participants who received 1 or more doses of study drug); n=all participants with a nonmissing value at given time point.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 29 29
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=14, 14, 13, 12) 100 100 100 100
Week 4 (n=13, 16, 15, 11) 100 100 100 100
Week 8 (n=13, 15, 13, 10) 100 100 100 100
Week 12 (n=14, 15, 13, 9) 100 100 100 100
Endpoint (n=19, 18, 16, 15) 100 100 100 100
8.Secondary Outcome
Title Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)
Hide Description The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates "core" symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression and scores less than 12 indicate mild depression.
Time Frame Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set (participants who received 1 or more doses of study drug) with a baseline S-HAM-D6 measurement; n=number of participants with nonmissing data at given time point.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 13 13 11 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=13, 13, 11, 13) 1.3  (1.49) 1.8  (1.07) 1.2  (1.72) 1.5  (1.33)
Change from BL at Week 2 (n=13, 13, 11, 11) -0.7  (1.38) -0.5  (2.63) 0.3  (1.49) 0.4  (1.29)
Change from BL at Week 4 (n=12, 12, 11, 10) -0.5  (1.62) 0.9  (2.68) -0.2  (1.47) 0.2  (2.97)
Change from BL at Week 8 (n=10, 11, 10, 9) 0.1  (1.60) 1.1  (4.68) -0.2  (1.40) 1.6  (3.05)
Change from BL at Week 12 (n=9, 10, 9, 8) 0.9  (2.80) 0.2  (2.74) 1.0  (2.65) -0.1  (2.17)
Change from BL at Endpoint (n=13, 13, 11, 13) 0.5  (2.54) -0.1  (2.43) 0.6  (2.54) 0.9  (4.41)
9.Secondary Outcome
Title Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)
Hide Description NPSG continuously records normal and abnormal physiological activity during an entire night. It documents the adequacy of sleep, including the frequency, duration, and total amounts of stage 1-2, stage 3-4 (slow wave sleep), and rapid eye movement (REM) sleep.
Time Frame Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (all participants who received 1 or more doses of study drug); n=number of participants with data at given time point.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 29 29
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline (BL; n=29, 30, 29, 29) 442.3  (19.60) 442.4  (18.38) 442.0  (19.07) 442.8  (19.16)
Change from BL at Week 2 (n=28, 29, 27, 24) -4.4  (29.62) 5.8  (27.14) -3.9  (38.10) -8.8  (41.85)
Change from BL at Week 4 (n=26, 28, 26, 21) -16.9  (78.81) 2.9  (34.50) 4.0  (41.32) -21.6  (51.18)
Change from BL at Week 12 (n=22, 26, 22, 15) -0.5  (24.39) 8.3  (20.46) -18.3  (62.26) -33.1  (55.65)
Change from BL at Endpoint (n=29, 30, 27, 26) -10.1  (35.75) 6.6  (21.37) -19.7  (60.53) -21.2  (46.77)
10.Secondary Outcome
Title Plasma Concentrations of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) at Weeks 4, 8, and 12 (or Last Postbaseline Observation Up to Week 12)
Hide Description To evaluate the impact of treatment with armodafinil on the pharmacokinetics of selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) (as appropriate), plasma concentrations at weeks 4, 8, and 12 (or last postbaseline observation) were to be assessed.
Time Frame Weeks 4, 8, and 12 (or last postbaseline observation, up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the limited samples available for measurement of concentrations of antidepressants in the study, the plasma concentrations of antidepressants were not measured. The planned pharmacokinetic evaluation of the impact of armodafinil treatment on the pharmacokinetics of selective antidepressants was not conducted.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Hide Description Therapeutic classification of concomitant medications used by ≥5% of participants throughout the study. Participants are counted only once in each therapeutic class category. Medications were included in the table if the proportion of participants in the combined armodafinil treatment group was ≥5%.
Time Frame Screening through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 29 29
Measure Type: Number
Unit of Measure: participants
Analgesics 4 4 7 6
Antibacterials 2 2 1 2
Antihistamines for systemic use 1 2 4 2
Anti-inflammatory and antirheumatic products 8 9 5 8
Drugs for acid-related disorders 0 2 2 2
Lipid-modifying agents 2 8 2 2
Nasal preparations 2 3 1 2
Sex hormones and modulators of the genital system 3 4 3 3
Unspecified herbal 1 3 1 1
Vitamins/nutritional supplement 5 7 4 7
12.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Hide Description AE=any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis (including hypomanic or manic episode), and seizure or suspected seizure were considered to be of potential clinical importance.
Time Frame Screening through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (all participants who received 1 or more doses of study drug).
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 29 29
Measure Type: Number
Unit of Measure: participants
Any adverse event 14 15 16 16
Severe adverse events 0 0 0 0
Treatment-related adverse events 8 9 14 15
Deaths 0 0 0 0
Other serious adverse events 0 0 0 0
Withdrawn from study due to adverse events 0 2 1 5
Protocol-defined adverse event 0 1 0 3
13.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
Hide Description Normal ranges for serum chemistry values: blood urea nitrogen (BUN), 1.43 - 8.57 mmol/L; uric acid, 124.91 - 493.68 μmol/L; aspartate aminotransferase (AST), 11 - 36 U/L; gamma-glutamyl transpeptidase (GGT), 10 - 61 U/L; total bilirubin, 3.42 - 20.52 μmol/L.
Time Frame Baseline, last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 28 28
Measure Type: Number
Unit of Measure: participants
BUN >=10.71 mmol/L 1 0 0 0
Uric acid >=625 (men) or >=506 (women) μmol/L 0 1 0 0
AST >=3 x upper limit of normal 0 0 1 0
GGT >=3 x upper limit of normal 0 1 0 0
Total bilirubin >=34.2 μmol/L 0 1 1 0
14.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values
Hide Description Normal ranges for hematology values: white blood cell (WBC) count, 3.8 - 10.7 x 10^9/L; absolute neutrophil count (ANC), 1.96 - 7.23 x 10^9/L. Participants may have had more than one clinically significant abnormal value.
Time Frame Baseline, last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 28 28
Measure Type: Number
Unit of Measure: participants
WBC <=3.0 x 10^9/L 1 1 1 0
ANC <=1.0 x 10^9/L 1 0 0 0
15.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values
Hide Description Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine >=2 units increase from baseline.
Time Frame Baseline, last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 28 28
Measure Type: Number
Unit of Measure: participants
2 1 1 1
16.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormal Vital Sign Values
Hide Description Criteria for clinically significant abnormal vital signs values: heart rate, ≤50 beats per minute (bpm) and decrease from baseline of ≥15 bpm; sitting systolic blood pressure, ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; sitting diastolic blood pressure, ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.
Time Frame Baseline, last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 28 29
Measure Type: Number
Unit of Measure: participants
Heart Rate 0 1 1 0
Sitting Systolic Blood Pressure 0 1 0 0
Sitting Diastolic Blood Pressure 0 1 0 0
17.Secondary Outcome
Title Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
Hide Description Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure, ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure, ≥90 mm Hg plus increase of ≥10% from baseline.
Time Frame Baseline, last postbaseline observation up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 28 29
Measure Type: Number
Unit of Measure: participants
Sitting Systolic Blood Pressure 0 1 1 2
Sitting Diastolic Blood Pressure 0 2 0 2
18.Secondary Outcome
Title Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Hide Description Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Shifts (normal and abnormal) from baseline to overall are summarized using participant counts. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event.
Time Frame Baseline through Endpoint (last postbaseline observation, up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 28 27 27 27
Measure Type: Number
Unit of Measure: participants
Normal at BL → Normal Overall 15 16 14 15
Normal at BL → Abnormal Overall 1 2 4 1
Abnormal at BL → Normal Overall 3 3 7 3
Abnormal at BL → Abnormal Overall 9 6 2 8
19.Secondary Outcome
Title Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Hide Description Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP, defined as last postbaseline observation, up to Week 12). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT=head, eyes, ears, nose, throat.
Time Frame Baseline through Endpoint (last postbaseline observation, up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
For each category, only participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description:
Oral placebo tablets, once daily (QD)
Oral armodafinil 50 mg tablets, once daily (QD)
Oral armodafinil 150 mg tablets, once daily (QD)
Oral armodafinil 250 mg tablets, once daily (QD)
Overall Number of Participants Analyzed 29 30 29 29
Measure Type: Number
Unit of Measure: participants
General Appearance: Normal at BL → Normal at EP 26 27 26 27
General Appearance: Normal at BL → Abnormal at EP 0 0 0 0
General Appearance: Abnormal at BL → Normal at EP 0 2 1 0
General Appearance:Abnormal at BL → Abnormal at EP 2 0 0 0
HEENT: Normal at BL→ Normal at EP 26 29 24 26
HEENT: Normal at BL→ Abnormal at EP 1 0 1 0
HEENT: Abnormal at BL→ Normal at BL 0 0 1 0
HEENT: Abnormal at BL→ Abnormal at EP 1 0 1 1
Chest/Lungs: Normal at BL→ Normal at EP 28 29 27 27
Chest/Lungs: Normal at BL→ Abnormal at EP 0 0 0 0
Chest/Lungs: Abnormal at BL→ Normal at EP 0 0 0 0
Chest/Lungs: Abnormal at BL→ Abnormal at EP 0 0 0 0
Heart: Normal at BL → Normal at EP 26 29 27 26
Heart: Normal at BL → Abnormal at EP 0 0 0 1
Heart: Abnormal at BL → Normal at EP 2 0 0 0
Heart: Abnormal at BL → Abnormal at EP 0 0 0 0
Abdomen: Normal at BL → Normal at EP 27 27 26 26
Abdomen: Normal at BL → Abnormal at EP 0 0 0 0
Abdomen: Abnormal at BL → Normal at EP 0 2 1 0
Abdomen: Abnormal at BL → Abnormal at EP 1 0 0 0
Musculoskeletal: Normal at BL → Normal at EP 27 29 25 27
Musculoskeletal: Normal at BL → Abnormal at EP 0 0 0 0
Musculoskeletal: Abnormal at BL → Normal at EP 1 0 1 0
Musculoskeletal: Abnormal at BL → Abnormal at EP 0 0 1 0
Skin: Normal at BL → Normal at EP 25 24 24 24
Skin: Normal at BL → Abnormal at EP 0 1 0 1
Skin: Abnormal at BL → Normal at EP 0 1 0 1
Skin: Abnormal at BL → Abnormal at EP 3 3 3 1
Lymph Nodes: Normal at BL → Normal at EP 25 26 24 27
Lymph Nodes: Normal at BL → Abnormal at EP 0 1 0 0
Lymph Nodes: Abnormal at BL → Normal at EP 0 0 1 0
Lymph Nodes: Abnormal at BL → Abnormal at EP 0 0 0 0
Neurological: Normal at BL → Normal at EP 26 28 27 27
Neurological: Normal at BL → Abnormal at EP 0 0 0 0
Neurological: Abnormal at BL → Normal at EP 0 1 0 0
Neurological: Abnormal at BL → Abnormal at EP 2 0 0 0
Time Frame Screening through Week 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Hide Arm/Group Description Oral placebo tablets, once daily (QD) Oral armodafinil 50 mg tablets, once daily (QD) Oral armodafinil 150 mg tablets, once daily (QD) Oral armodafinil 250 mg tablets, once daily (QD)
All-Cause Mortality
Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%)   0/29 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Armodafinil 50 mg/Day Armodafinil 150 mg/Day Armodafinil 250 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/29 (48.28%)   15/30 (50.00%)   16/29 (55.17%)   16/29 (55.17%) 
Blood and lymphatic system disorders         
Lymphadenopathy  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Cardiac disorders         
Palpitations  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Eye disorders         
Vision blurred  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Conjunctival haemorrhage  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Gastrointestinal disorders         
Nausea  1  0/29 (0.00%)  3/30 (10.00%)  3/29 (10.34%)  3/29 (10.34%) 
Diarrhoea  1  1/29 (3.45%)  1/30 (3.33%)  0/29 (0.00%)  3/29 (10.34%) 
Dry mouth  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  2/29 (6.90%) 
Abdominal discomfort  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Abdominal pain  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Gastroesophageal reflux disease  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Toothache  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
General disorders         
Feeling jittery  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  2/29 (6.90%) 
Fatigue  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Feeling abnormal  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Irritability  1  1/29 (3.45%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Pyrexia  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Infections and infestations         
Upper respiratory tract infection  1  1/29 (3.45%)  1/30 (3.33%)  3/29 (10.34%)  0/29 (0.00%) 
Sinusitis  1  1/29 (3.45%)  1/30 (3.33%)  0/29 (0.00%)  2/29 (6.90%) 
Influenza  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  1/29 (3.45%) 
Nasopharyngitis  1  0/29 (0.00%)  1/30 (3.33%)  1/29 (3.45%)  0/29 (0.00%) 
Pharyngitis  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Pharyngitis streptococcal  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Rhinitis  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Urinary tract infection  1  1/29 (3.45%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Kidney infection  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Pneumonia  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Viral infection  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod sting  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Contusion  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1  1/29 (3.45%)  1/30 (3.33%)  0/29 (0.00%)  1/29 (3.45%) 
Heart rate increased  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  1/29 (3.45%) 
Alanine aminotransferase increased  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Blood alkaline phosphatase increased  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Blood bicarbonate decreased  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Blood potassium increased  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Blood pressure increased  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Blood sodium increased  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Platelet count decreased  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Weight decreased  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Weight increased  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Blood creatinine increased  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Electrocardiogram T wave abnormal  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Glucose urine present  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  1/29 (3.45%) 
Hyperglycaemia  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Flank pain  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Musculoskeletal pain  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Back pain  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Nervous system disorders         
Headache  1  2/29 (6.90%)  5/30 (16.67%)  5/29 (17.24%)  5/29 (17.24%) 
Dizziness  1  0/29 (0.00%)  2/30 (6.67%)  1/29 (3.45%)  2/29 (6.90%) 
Memory impairment  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Sinus headache  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Somnolence  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Unintended pregnancy  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/29 (0.00%)  4/30 (13.33%)  0/29 (0.00%)  3/29 (10.34%) 
Insomnia  1  1/29 (3.45%)  1/30 (3.33%)  3/29 (10.34%)  1/29 (3.45%) 
Bruxism  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  1/29 (3.45%) 
Depression  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  2/29 (6.90%) 
Initial insomnia  1  0/29 (0.00%)  1/30 (3.33%)  1/29 (3.45%)  0/29 (0.00%) 
Logorrhoea  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Middle insomnia  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Tachyphrenia  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Abnormal dreams  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Nightmare  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Pressure of speech  1  1/29 (3.45%)  0/30 (0.00%)  0/29 (0.00%)  0/29 (0.00%) 
Renal and urinary disorders         
Haematuria  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Dyspnoea  1  0/29 (0.00%)  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Oropharyngeal pain  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  2/29 (6.90%) 
Eczema  1  0/29 (0.00%)  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Skin irritation  1  0/29 (0.00%)  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
The sponsor’s decision to terminate the study early resulted in a small number of study participants and related limitations to the interpretation of the study results.
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00893789     History of Changes
Other Study ID Numbers: C10953/3067/ES/MN
First Submitted: May 4, 2009
First Posted: May 6, 2009
Results First Submitted: May 9, 2013
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013