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A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

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: NCT01160380
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Oncotherapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Fatigue
Multiple Myeloma
Interventions Drug: armodafinil
Drug: Placebo
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Period Title: Overall Study
Started 25 25
Completed 17 20
Not Completed 8 5
Arm/Group Title Armodafinil Placebo-First Total
Hide Arm/Group Description

The patients receive armodafinil for all 56 days of the study.

armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
63  (1.8) 67  (2.3) 65  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
14
  56.0%
15
  60.0%
29
  58.0%
Male
11
  44.0%
10
  40.0%
21
  42.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  28.0%
1
   4.0%
8
  16.0%
White
17
  68.0%
20
  80.0%
37
  74.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.0%
3
  12.0%
4
   8.0%
ECOG (Eastern Cooperative Oncology Group)   [1] 
Measure Type: Number
Unit of measure:  Paarticipants
Number Analyzed 25 participants 25 participants 50 participants
0 5 7 12
1 18 17 35
2 2 1 3
[1]
Measure Description:

Grade ECOG Performance status

0 Fully active, performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
  4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
  5. Dead
Fatigue (baseline)-Brief Fatigue Inventory (BFI)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 50 participants
59
(39 to 83)
60.5
(36 to 79)
60
(36 to 83)
[1]
Measure Description: BFI scale: 9 items; range=0-90 (0-10 per item) Mild = 1-3 Moderate = 4-7 Severe = 8-10
Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 50 participants
9
(6 to 12)
9
(6 to 12)
9
(6 to 12)
[1]
Measure Description: ICD-10 Criteria (Range: 0-14) A1-A11 Fatigue Criteria B. Clinically significant distress or impaired functioning C. Symptoms are a consequence of cancer or cancer therapy D. Symptoms are a consequence of comorbid psychiatric disorders
1.Primary Outcome
Title BFI Score
Hide Description Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10
Time Frame Day 1, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description:

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1(n=18, 23) 65.0  (13.2) 57.2  (14.3)
Day 28 (n=19, 23) 48.8  (22.4) 41.5  (18.4)
Day 56 (n=15) 43.2  (18.9) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at Day 28 of treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.289
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Comparison between Day 1 and Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Comparison between Day 1 and day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Comparison between Day 28 and Day 56 of treatment for the armodafinil arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Trail Making Test B Score (TMT-B)
Hide Description

Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.

The test evaluates the time to correctly order letters and numbers; low times = better performance.

Time Frame Day 1, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description:

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: seconds
Day 1(n=18, 23) 161.3  (77.8) 220.5  (163.2)
Day 28 (n=19, 23) 158.4  (81.2) 159.8  (94.2)
Day 56 (n=15) 153.8  (78.7) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at Day 28 of treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. Day 28 of treatment for the Armodafinil arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.369
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Symbol Digit Modalities Test Score (SDMT)
Hide Description Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance
Time Frame Day 1, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description:

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Number of correct matches
Day 1(n=18, 23) 41.2  (9.2) 40.7  (14.7)
Day 28 (n=19, 23) 42.4  (12.0) 40.8  (14.7)
Day 56 (n=15) 48.7  (12.3) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.699
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. Day 28 of treatment for the Armodafinil arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.239
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. Day 56 of treatment for the Armodafinil arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Digit Span Test Score
Hide Description Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.
Time Frame Day 1, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description:

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Number of correct items
Forward-Day 1 (n=18, 23) 9.5  (2.7) 9.8  (2.6)
Backward-Day 1 (n=18, 23) 7.3  (2.0) 6.3  (2.4)
Forward-Day 28 (n=19, 23) 10.6  (3.0) 10.4  (2.3)
Backward- Day 28 (n=19, 23) 7.0  (2.6) 7.0  (2.6)
Forward-Day 56 (n=15) 10.3  (2.8) NA [1]   (NA)
Backward-Day 56 (n=15) 7.4  (2.8) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.636
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.692
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score
Hide Description Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).
Time Frame Day 1, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description:

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
PWB-Day 1 (n=18, 23) 14.1  (3.3) 15.3  (5.1)
SWB-Day 1 (n=18, 23) 20.9  (6.7) 19.8  (5.1)
EWB-Day 1 (n=18, 23) 16.9  (4.3) 17.5  (3.7)
FWB-Day 1 (n=18, 23) 14.8  (3.6) 14.6  (4.2)
Fatigue-Day 1 (n=18, 23) 19.2  (8.7) 18.8  (8.9)
FACIT-G-Day 1 (n=18, 23) 67.0  (11.6) 68.9  (11.4)
TOI-Day 1 (n=18, 23) 49.0  (12.2) 49.4  (15.3)
Total-Day 1 (n=19, 23) 86.2  (15.8) 86.1  (20.4)
PWB-Day 28 (n=19, 23) 16.5  (6.6) 17.4  (6.3)
EWB-Day 28 (n=19, 23) 16.5  (5.3) 18.7  (4.3)
SWB-Day 28 (n=19, 23) 21.3  (7.5) 20.8  (5.4)
FWB-Day 28 (n=19, 23) 14.4  (5.1) 16.8  (4.5)
Fatigue-Day 28 (n=19, 23) 28.0  (13.22) 26.5  (11.7)
FACIT-G-Day 28 (n=19, 23) 68.5  (20.5) 75.8  (12.9)
TOI-Day 28 (n=19, 23) 59.4  (23.5) 62.9  (18.7)
Total-Day 28 (n=19, 23) 96.5  (31.3) 101.3  (21.9)
PWB-Day 56 (n=15) 17.8  (5.1) NA [1]   (NA)
EWB-Day 56 (n=15) 22.1  (5.7) NA [1]   (NA)
SWB-Day 56 (n=15) 18.7  (3.4) NA [1]   (NA)
FWB-Day 56 (n=15) 13.5  (3.8) NA [1]   (NA)
Fatigue-Day 56 (n=15) 29.7  (9.2) NA [1]   (NA)
FACIT-G-Day 56 (n=15) 73.2  (12.1) NA [1]   (NA)
TOI-Day 56 (n=15) 62.7  (14.6) NA [1]   (NA)
Total-Day 56 (n=15) 101.8  (18.7) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms for Day 28 of treatment- FACIT-F total
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.559
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) Score
Hide Description Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.
Time Frame Day 1, Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
Hide Arm/Group Description:

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: units on a scale
Anxiety-Day 1 (n=18, 23) 13.4  (21.4) 8.3  (2.9)
Depression-Day 1 (n=18, 23) 7.8  (2.7) 7.6  (3.2)
Anxiety-Day 28 (n=19, 23) 6.9  (4.6) 5.5  (3.3)
Depression-Day 28 (n=19, 23) 10.3  (17.8) 6.6  (3.6)
Anxiety-Day 56 (n=15) 7.0  (3.4) NA [1]   (NA)
Depression-Day 56 (n=15) 5.7  (2.9) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at Day 28 of treatment- HADS anxiety
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.945
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms at Day 28 of treatment- HADS depression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Epworth Sleepiness Scale (ESS) Score
Hide Description Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness
Time Frame Day 1, Day 28 and Day 56
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo-First
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The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1(n=18, 23) 12.2  (5.1) 11.5  (4.5)
Day 28 (n=19, 23) 10.1  (5.1) 10.0  (4.6)
Day 56 (n=15) 11.5  (4.5) NA [1]   (NA)
[1]
Day 56 data was only evaluated for the Armodafinil arm
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Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo-First
Comments Comparison between arms for Day 28 of treatment -ESS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.840
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo-First
Comments Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 1 and Day 28 of treatment for the Armodafinil arm- ESS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Armodafinil
Comments Day 28 vs. Day 56 of treatment for the Armodafinil arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil Placebo-First
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The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

AEs presented were those occurring during from Day 1 to Day 28 only

All-Cause Mortality
Armodafinil Placebo-First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil Placebo-First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      0/25 (0.00%)    
Eye disorders     
Ptosis *  1/50 (2.00%)  1 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  1/50 (2.00%)  1 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Armodafinil Placebo-First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/50 (30.00%)      2/25 (8.00%)    
Blood and lymphatic system disorders     
G3/G4 Leukopenia *  2/50 (4.00%)  2 1/25 (4.00%)  1
G3/G4 Lymphopenia *  3/50 (6.00%)  3 1/25 (4.00%)  1
G3/G4 Neutropenia *  2/50 (4.00%)  2 0/25 (0.00%)  0
G3/G4 Eosinophils (increased) *  1/50 (2.00%)  1 0/25 (0.00%)  0
Ear and labyrinth disorders     
G3/G4 Infection (ear) *  1/50 (2.00%)  1 0/25 (0.00%)  0
General disorders     
G4 Edema *  1/50 (2.00%)  1 0/25 (0.00%)  0
Infections and infestations     
G3/G4 Upper Respiratory Infection *  1/50 (2.00%)  1 0/25 (0.00%)  0
Metabolism and nutrition disorders     
G3/G4 Hypokalemia *  1/50 (2.00%)  1 0/25 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
G3/G4 Neuroma *  1/50 (2.00%)  1 0/25 (0.00%)  0
Renal and urinary disorders     
G3/G4 BUN (increased) *  1/50 (2.00%)  1 0/25 (0.00%)  0
G3/G4 Creatinine (increased) *  1/50 (2.00%)  1 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Director of Clinical Operations
Organization: Oncotherapeutics
Phone: 310-623-1200
EMail: lthulin@oncotherapeutics.com
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Responsible Party: Oncotherapeutics
ClinicalTrials.gov Identifier: NCT01160380     History of Changes
Other Study ID Numbers: C10953/6270
First Submitted: July 7, 2010
First Posted: July 12, 2010
Results First Submitted: October 22, 2014
Results First Posted: November 6, 2014
Last Update Posted: November 6, 2014