Trial Outcomes & Findings for 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 (NCT NCT00893789)
NCT ID: NCT00893789
Last Updated: 2021-12-17
Results Overview
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.
TERMINATED
PHASE3
117 participants
Baseline, last postbaseline observation up to Week 12
2021-12-17
Participant Flow
Participant milestones
| Measure |
Placebo
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
29
|
29
|
|
Overall Study
Safety Analysis Set (SAS)
|
29
|
30
|
29
|
29
|
|
Overall Study
Full Analysis Set (FAS)
|
29
|
29
|
28
|
27
|
|
Overall Study
COMPLETED
|
23
|
26
|
22
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
7
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
3
|
1
|
|
Overall Study
Noncompliance With Study Drug
|
1
|
0
|
1
|
2
|
|
Overall Study
Noncompliance With Study Procedures
|
1
|
0
|
0
|
0
|
|
Overall Study
Taking Excluded Concomitant Medication
|
1
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 11.02 • n=93 Participants
|
33.2 years
STANDARD_DEVIATION 9.31 • n=4 Participants
|
32.3 years
STANDARD_DEVIATION 10.81 • n=27 Participants
|
29.4 years
STANDARD_DEVIATION 11.07 • n=483 Participants
|
31.3 years
STANDARD_DEVIATION 10.54 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
64 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
4 participants
n=483 Participants
|
14 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
26 participants
n=93 Participants
|
27 participants
n=4 Participants
|
22 participants
n=27 Participants
|
24 participants
n=483 Participants
|
99 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, last postbaseline observation up to Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=29 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=27 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)
Baseline (BL; n=29, 29, 28, 27)
|
3.3 minutes
Standard Deviation 1.79
|
4.2 minutes
Standard Deviation 1.69
|
4.2 minutes
Standard Deviation 2.05
|
3.7 minutes
Standard Deviation 2.04
|
|
Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)
Change from BL at Endpoint (n=27, 29, 26, 21)
|
2.4 minutes
Standard Deviation 4.03
|
2.6 minutes
Standard Deviation 4.35
|
5.0 minutes
Standard Deviation 4.95
|
7.2 minutes
Standard Deviation 6.35
|
PRIMARY outcome
Timeframe: Last postbaseline observation up to Week 12Population: Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment).
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=29 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=27 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)
Responders
|
38 percentage of participants
|
41 percentage of participants
|
54 percentage of participants
|
48 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)
Nonresponders
|
62 percentage of participants
|
59 percentage of participants
|
46 percentage of participants
|
52 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=29 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=27 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12
Baseline (BL; n=29, 29, 28, 27)
|
3.3 minutes
Standard Deviation 1.79
|
4.2 minutes
Standard Deviation 1.69
|
4.2 minutes
Standard Deviation 2.05
|
3.7 minutes
Standard Deviation 2.04
|
|
Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12
Change from BL at Week 4 (n=26, 29, 26, 20)
|
3.2 minutes
Standard Deviation 4.93
|
2.7 minutes
Standard Deviation 5.21
|
4.0 minutes
Standard Deviation 5.43
|
7.0 minutes
Standard Deviation 4.80
|
|
Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12
Change from BL at Week 8 (n=24, 27, 24, 17)
|
2.1 minutes
Standard Deviation 4.73
|
2.5 minutes
Standard Deviation 4.88
|
4.2 minutes
Standard Deviation 5.94
|
4.2 minutes
Standard Deviation 5.47
|
|
Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12
Change from BL at Week 12 (n=22, 26, 22, 15)
|
1.8 minutes
Standard Deviation 3.87
|
2.7 minutes
Standard Deviation 4.53
|
4.6 minutes
Standard Deviation 4.39
|
7.4 minutes
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=29 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=27 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 2 Responders (n=28, 29, 27, 23)
|
14 percentage of participants
|
21 percentage of participants
|
37 percentage of participants
|
39 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 4 Responders (n=27, 29, 26, 20)
|
22 percentage of participants
|
24 percentage of participants
|
50 percentage of participants
|
50 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 4 Nonresponders (n=27, 29, 26, 20)
|
78 percentage of participants
|
76 percentage of participants
|
50 percentage of participants
|
50 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 8 Responders (n=23, 27, 24, 18)
|
35 percentage of participants
|
48 percentage of participants
|
54 percentage of participants
|
56 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 12 Nonresponders (n=23, 26, 22, 16)
|
65 percentage of participants
|
58 percentage of participants
|
45 percentage of participants
|
44 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 2 Nonresponders (n=28, 29, 27, 23)
|
86 percentage of participants
|
79 percentage of participants
|
63 percentage of participants
|
61 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 8 Nonresponders (n=23, 27, 24, 18)
|
65 percentage of participants
|
52 percentage of participants
|
46 percentage of participants
|
44 percentage of participants
|
|
Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12
Week 12 Responders (n=23, 26, 22, 16)
|
35 percentage of participants
|
42 percentage of participants
|
55 percentage of participants
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=24 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=24 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=19 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=21 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
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)
Baseline (BL; n=24, 24, 19, 21)
|
8.5 units on a scale
Standard Deviation 6.75
|
9.3 units on a scale
Standard Deviation 8.80
|
8.7 units on a scale
Standard Deviation 7.55
|
11.6 units on a scale
Standard Deviation 10.71
|
|
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)
Change from BL at Week 8 (n=19, 22, 17, 13)
|
-1.4 units on a scale
Standard Deviation 5.52
|
-3.5 units on a scale
Standard Deviation 4.94
|
-2.4 units on a scale
Standard Deviation 5.26
|
-4.7 units on a scale
Standard Deviation 8.89
|
|
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)
Change from BL at Week 12 (n=19, 21, 17, 12)
|
-0.9 units on a scale
Standard Deviation 6.27
|
-3.9 units on a scale
Standard Deviation 4.74
|
-2.5 units on a scale
Standard Deviation 4.32
|
-5.0 units on a scale
Standard Deviation 6.90
|
|
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)
Change from BL at Endpoint (n=24, 24, 19, 19)
|
-2.3 units on a scale
Standard Deviation 6.44
|
-3.4 units on a scale
Standard Deviation 4.60
|
-2.5 units on a scale
Standard Deviation 4.07
|
-2.5 units on a scale
Standard Deviation 7.12
|
|
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)
Change from BL at Week 4 (n=23, 23, 18, 15)
|
-2.5 units on a scale
Standard Deviation 4.71
|
-2.5 units on a scale
Standard Deviation 3.72
|
-0.5 units on a scale
Standard Deviation 3.71
|
-2.8 units on a scale
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=29 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=27 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
Baseline (BL; n=29, 29, 28, 27)
|
14.8 units on a scale
Standard Deviation 2.83
|
14.3 units on a scale
Standard Deviation 2.61
|
15.1 units on a scale
Standard Deviation 2.54
|
16.1 units on a scale
Standard Deviation 3.82
|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
Change from BL at Week 12 (n=23, 26, 22, 16)
|
-5.0 units on a scale
Standard Deviation 6.12
|
-4.6 units on a scale
Standard Deviation 5.30
|
-6.5 units on a scale
Standard Deviation 4.40
|
-9.2 units on a scale
Standard Deviation 4.90
|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)
Change from BL at Endpoint (n=27, 28, 26, 23)
|
-5.1 units on a scale
Standard Deviation 5.93
|
-4.5 units on a scale
Standard Deviation 5.15
|
-6.1 units on a scale
Standard Deviation 4.52
|
-7.0 units on a scale
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
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)
Week 2 (n=14, 14, 13, 12)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
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)
Week 4 (n=13, 16, 15, 11)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
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)
Week 8 (n=13, 15, 13, 10)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
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)
Week 12 (n=14, 15, 13, 9)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
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)
Endpoint (n=19, 18, 16, 15)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=13 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=13 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=11 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=13 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
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)
Change from BL at Week 4 (n=12, 12, 11, 10)
|
-0.5 units on a scale
Standard Deviation 1.62
|
0.9 units on a scale
Standard Deviation 2.68
|
-0.2 units on a scale
Standard Deviation 1.47
|
0.2 units on a scale
Standard Deviation 2.97
|
|
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)
Change from BL at Week 8 (n=10, 11, 10, 9)
|
0.1 units on a scale
Standard Deviation 1.60
|
1.1 units on a scale
Standard Deviation 4.68
|
-0.2 units on a scale
Standard Deviation 1.40
|
1.6 units on a scale
Standard Deviation 3.05
|
|
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)
Baseline (BL; n=13, 13, 11, 13)
|
1.3 units on a scale
Standard Deviation 1.49
|
1.8 units on a scale
Standard Deviation 1.07
|
1.2 units on a scale
Standard Deviation 1.72
|
1.5 units on a scale
Standard Deviation 1.33
|
|
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)
Change from BL at Week 2 (n=13, 13, 11, 11)
|
-0.7 units on a scale
Standard Deviation 1.38
|
-0.5 units on a scale
Standard Deviation 2.63
|
0.3 units on a scale
Standard Deviation 1.49
|
0.4 units on a scale
Standard Deviation 1.29
|
|
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)
Change from BL at Week 12 (n=9, 10, 9, 8)
|
0.9 units on a scale
Standard Deviation 2.80
|
0.2 units on a scale
Standard Deviation 2.74
|
1.0 units on a scale
Standard Deviation 2.65
|
-0.1 units on a scale
Standard Deviation 2.17
|
|
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)
Change from BL at Endpoint (n=13, 13, 11, 13)
|
0.5 units on a scale
Standard Deviation 2.54
|
-0.1 units on a scale
Standard Deviation 2.43
|
0.6 units on a scale
Standard Deviation 2.54
|
0.9 units on a scale
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)Population: Safety Analysis Set (all participants who received 1 or more doses of study drug); n=number of participants with data at given time point.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
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)
Change from BL at Week 12 (n=22, 26, 22, 15)
|
-0.5 minutes
Standard Deviation 24.39
|
8.3 minutes
Standard Deviation 20.46
|
-18.3 minutes
Standard Deviation 62.26
|
-33.1 minutes
Standard Deviation 55.65
|
|
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)
Change from BL at Endpoint (n=29, 30, 27, 26)
|
-10.1 minutes
Standard Deviation 35.75
|
6.6 minutes
Standard Deviation 21.37
|
-19.7 minutes
Standard Deviation 60.53
|
-21.2 minutes
Standard Deviation 46.77
|
|
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)
Baseline (BL; n=29, 30, 29, 29)
|
442.3 minutes
Standard Deviation 19.60
|
442.4 minutes
Standard Deviation 18.38
|
442.0 minutes
Standard Deviation 19.07
|
442.8 minutes
Standard Deviation 19.16
|
|
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)
Change from BL at Week 2 (n=28, 29, 27, 24)
|
-4.4 minutes
Standard Deviation 29.62
|
5.8 minutes
Standard Deviation 27.14
|
-3.9 minutes
Standard Deviation 38.10
|
-8.8 minutes
Standard Deviation 41.85
|
|
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)
Change from BL at Week 4 (n=26, 28, 26, 21)
|
-16.9 minutes
Standard Deviation 78.81
|
2.9 minutes
Standard Deviation 34.50
|
4.0 minutes
Standard Deviation 41.32
|
-21.6 minutes
Standard Deviation 51.18
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 12 (or last postbaseline observation, up to Week 12)Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening through Week 12Population: All randomized participants
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%.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Antihistamines for systemic use
|
1 participants
|
2 participants
|
4 participants
|
2 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Drugs for acid-related disorders
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Lipid-modifying agents
|
2 participants
|
8 participants
|
2 participants
|
2 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Nasal preparations
|
2 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Sex hormones and modulators of the genital system
|
3 participants
|
4 participants
|
3 participants
|
3 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Unspecified herbal
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Analgesics
|
4 participants
|
4 participants
|
7 participants
|
6 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Antibacterials
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Anti-inflammatory and antirheumatic products
|
8 participants
|
9 participants
|
5 participants
|
8 participants
|
|
Concomitant Medication Usage In ≥5% of Participants Throughout the Study
Vitamins/nutritional supplement
|
5 participants
|
7 participants
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Screening through Week 12Population: Safety Analysis Set (all participants who received 1 or more doses of study drug).
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Any adverse event
|
14 participants
|
15 participants
|
16 participants
|
16 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Severe adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Treatment-related adverse events
|
8 participants
|
9 participants
|
14 participants
|
15 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Withdrawn from study due to adverse events
|
0 participants
|
2 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Other serious adverse events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs
Protocol-defined adverse event
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, last postbaseline observation up to Week 12Population: Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=28 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
BUN >=10.71 mmol/L
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
AST >=3 x upper limit of normal
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
GGT >=3 x upper limit of normal
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
Total bilirubin >=34.2 μmol/L
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values
Uric acid >=625 (men) or >=506 (women) μmol/L
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, last postbaseline observation up to Week 12Population: Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=28 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values
WBC <=3.0 x 10^9/L
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values
ANC <=1.0 x 10^9/L
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, last postbaseline observation up to Week 12Population: Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine \>=2 units increase from baseline.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=28 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, last postbaseline observation up to Week 12Population: Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Sitting Diastolic Blood Pressure
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Heart Rate
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Sitting Systolic Blood Pressure
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, last postbaseline observation up to Week 12Population: Participants in the Safety Analysis Set with a baseline and postbaseline measurement.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=28 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
Sitting Systolic Blood Pressure
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
Sitting Diastolic Blood Pressure
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline through Endpoint (last postbaseline observation, up to Week 12)Population: Participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.
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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=27 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=27 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=27 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Normal at BL → Abnormal Overall
|
1 participants
|
2 participants
|
4 participants
|
1 participants
|
|
Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Abnormal at BL → Normal Overall
|
3 participants
|
3 participants
|
7 participants
|
3 participants
|
|
Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Normal at BL → Normal Overall
|
15 participants
|
16 participants
|
14 participants
|
15 participants
|
|
Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Abnormal at BL → Abnormal Overall
|
9 participants
|
6 participants
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline through Endpoint (last postbaseline observation, up to Week 12)Population: For each category, only participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 Participants
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 Participants
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 Participants
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Musculoskeletal: Normal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
General Appearance: Abnormal at BL → Normal at EP
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
HEENT: Normal at BL→ Abnormal at EP
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
HEENT: Abnormal at BL→ Abnormal at EP
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Chest/Lungs: Abnormal at BL→ Normal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Heart: Normal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Abdomen: Normal at BL → Normal at EP
|
27 participants
|
27 participants
|
26 participants
|
26 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Abdomen: Normal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Abdomen: Abnormal at BL → Normal at EP
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Abdomen: Abnormal at BL → Abnormal at EP
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Musculoskeletal: Normal at BL → Normal at EP
|
27 participants
|
29 participants
|
25 participants
|
27 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Musculoskeletal: Abnormal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Skin: Normal at BL → Normal at EP
|
25 participants
|
24 participants
|
24 participants
|
24 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
HEENT: Abnormal at BL→ Normal at BL
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Chest/Lungs: Normal at BL→ Normal at EP
|
28 participants
|
29 participants
|
27 participants
|
27 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Chest/Lungs: Normal at BL→ Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Chest/Lungs: Abnormal at BL→ Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Heart: Normal at BL → Normal at EP
|
26 participants
|
29 participants
|
27 participants
|
26 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Heart: Abnormal at BL → Normal at EP
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Heart: Abnormal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Musculoskeletal: Abnormal at BL → Normal at EP
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Skin: Normal at BL → Abnormal at EP
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Skin: Abnormal at BL → Normal at EP
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Skin: Abnormal at BL → Abnormal at EP
|
3 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Lymph Nodes: Normal at BL → Normal at EP
|
25 participants
|
26 participants
|
24 participants
|
27 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Lymph Nodes: Normal at BL → Abnormal at EP
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Lymph Nodes: Abnormal at BL → Normal at EP
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Lymph Nodes: Abnormal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Neurological: Normal at BL → Normal at EP
|
26 participants
|
28 participants
|
27 participants
|
27 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Neurological: Normal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Neurological: Abnormal at BL → Normal at EP
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
Neurological: Abnormal at BL → Abnormal at EP
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
General Appearance: Normal at BL → Normal at EP
|
26 participants
|
27 participants
|
26 participants
|
27 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
General Appearance: Normal at BL → Abnormal at EP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
General Appearance:Abnormal at BL → Abnormal at EP
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)
HEENT: Normal at BL→ Normal at EP
|
26 participants
|
29 participants
|
24 participants
|
26 participants
|
Adverse Events
Placebo
Armodafinil 50 mg/Day
Armodafinil 150 mg/Day
Armodafinil 250 mg/Day
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Oral placebo tablets, once daily (QD)
|
Armodafinil 50 mg/Day
n=30 participants at risk
Oral armodafinil 50 mg tablets, once daily (QD)
|
Armodafinil 150 mg/Day
n=29 participants at risk
Oral armodafinil 150 mg tablets, once daily (QD)
|
Armodafinil 250 mg/Day
n=29 participants at risk
Oral armodafinil 250 mg tablets, once daily (QD)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Eye disorders
Vision blurred
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Eye disorders
Conjunctival haemorrhage
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Screening through Week 12
|
10.0%
3/30 • Screening through Week 12
|
10.3%
3/29 • Screening through Week 12
|
10.3%
3/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
10.3%
3/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
6.9%
2/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
General disorders
Feeling jittery
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
6.9%
2/29 • Screening through Week 12
|
|
General disorders
Fatigue
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
General disorders
Feeling abnormal
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
General disorders
Irritability
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
10.3%
3/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
6.9%
2/29 • Screening through Week 12
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Infections and infestations
Rhinitis
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Infections and infestations
Kidney infection
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Infections and infestations
Viral infection
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Blood creatine phosphokinase increased
|
3.4%
1/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Investigations
Heart rate increased
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Blood potassium increased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Blood pressure increased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Investigations
Blood sodium increased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Platelet count decreased
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Weight decreased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Investigations
Weight increased
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Blood creatinine increased
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Electrocardiogram T wave abnormal
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Investigations
Glucose urine present
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Screening through Week 12
|
16.7%
5/30 • Screening through Week 12
|
17.2%
5/29 • Screening through Week 12
|
17.2%
5/29 • Screening through Week 12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Screening through Week 12
|
6.7%
2/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
6.9%
2/29 • Screening through Week 12
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Nervous system disorders
Somnolence
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/29 • Screening through Week 12
|
13.3%
4/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
10.3%
3/29 • Screening through Week 12
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
10.3%
3/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
6.9%
2/29 • Screening through Week 12
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Psychiatric disorders
Logorrhoea
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Psychiatric disorders
Tachyphrenia
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Psychiatric disorders
Abnormal dreams
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Psychiatric disorders
Nightmare
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Psychiatric disorders
Pressure of speech
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
6.9%
2/29 • Screening through Week 12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/29 • Screening through Week 12
|
3.3%
1/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/29 • Screening through Week 12
|
0.00%
0/30 • Screening through Week 12
|
0.00%
0/29 • Screening through Week 12
|
3.4%
1/29 • Screening through Week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER