Trial Outcomes & Findings for Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) (NCT NCT00981084)
NCT ID: NCT00981084
Last Updated: 2013-10-14
Results Overview
Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Results posted on
2013-10-14
Participant Flow
Participants who demonstrated at least mild cognitive impairment on a screening measure were recruited from a large MS neurology clinic in the Midwest from 2009 to 2011.
Participant milestones
| Measure |
Armodafinil First and Placebo Second
Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
|
Placebo First and Armodafinil Second
Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
|
|---|---|---|
|
First Intervention (One Day)
STARTED
|
16
|
17
|
|
First Intervention (One Day)
COMPLETED
|
16
|
17
|
|
First Intervention (One Day)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (7 Days)
STARTED
|
16
|
17
|
|
Washout Period (7 Days)
COMPLETED
|
16
|
17
|
|
Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (One Day)
STARTED
|
16
|
17
|
|
Second Intervention (One Day)
COMPLETED
|
16
|
17
|
|
Second Intervention (One Day)
NOT COMPLETED
|
0
|
0
|
|
Post Intervention (Data Analysis)
STARTED
|
16
|
17
|
|
Post Intervention (Data Analysis)
COMPLETED
|
14
|
16
|
|
Post Intervention (Data Analysis)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Armodafinil First and Placebo Second
Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
|
Placebo First and Armodafinil Second
Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
|
|---|---|---|
|
Post Intervention (Data Analysis)
poor effort
|
1
|
1
|
|
Post Intervention (Data Analysis)
imbalance in disease subtype
|
1
|
0
|
Baseline Characteristics
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Armodafinil Then Placebo
n=16 Participants
All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
armodafinil : Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.
|
Placebo Then Armodafinil
n=17 Participants
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
47.71 years
STANDARD_DEVIATION 5.89 • n=5 Participants
|
49.94 years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
49.15 years
STANDARD_DEVIATION 6.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12).
Outcome measures
| Measure |
Placebo/Armofafinil
n=16 Participants
placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
Armodafinil/Placebo
n=14 Participants
armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
|---|---|---|
|
Learning and Memory Measures.
Auditory Verbal Learning Test - Learning
|
-3.38 Items recalled
Standard Deviation 7.32
|
-.07 Items recalled
Standard Deviation 6.06
|
|
Learning and Memory Measures.
Aditory Verbal Learning Test Delay
|
-1.38 Items recalled
Standard Deviation 1.89
|
1.93 Items recalled
Standard Deviation 2.70
|
|
Learning and Memory Measures.
Brief Visuospatial Memory Test Learning
|
.88 Items recalled
Standard Deviation 4.63
|
-1.57 Items recalled
Standard Deviation 5.71
|
|
Learning and Memory Measures.
Brief Visuospatial Memory Test Delay
|
.56 Items recalled
Standard Deviation 1.50
|
-.57 Items recalled
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores. Continuous Performance Test (CPT) - Vigilance and reaction time.
Outcome measures
| Measure |
Placebo/Armofafinil
n=16 Participants
placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
Armodafinil/Placebo
n=14 Participants
armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
|---|---|---|
|
CPT -Test of Information Processing Speed
|
-1.18 milliseconds
Standard Deviation 37.62
|
15.04 milliseconds
Standard Deviation 50.30
|
PRIMARY outcome
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Outcome measures
| Measure |
Placebo/Armofafinil
n=16 Participants
placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
Armodafinil/Placebo
n=14 Participants
armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
|---|---|---|
|
Stroop
|
-1.69 number of colors named
Standard Deviation 3.38
|
-2.86 number of colors named
Standard Deviation 3.72
|
PRIMARY outcome
Timeframe: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.
Outcome measures
| Measure |
Placebo/Armofafinil
n=16 Participants
placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
Armodafinil/Placebo
n=14 Participants
armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
|
|---|---|---|
|
Word Generation
|
-.69 number of words generated
Standard Deviation 5.21
|
-1.71 number of words generated
Standard Deviation 3.24
|
Adverse Events
Placebo Then Armodafinil (Placebo)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Armodafinil Then Placebo (Armodafinil)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Then Armodafinil (Armodafinil)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Armodafinil Then Placebo (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Then Armodafinil (Placebo)
n=17 participants at risk
Adverse events reported after taking placebo in the Placebo then Armodafinil Group
|
Armodafinil Then Placebo (Armodafinil)
n=16 participants at risk
Adverse events reported after taking armodafinil in the Armodafinil then placebo group
|
Placebo Then Armodafinil (Armodafinil)
n=17 participants at risk
Adverse events following armodafinil in the placebo/armodafinil group
|
Armodafinil Then Placebo (Placebo)
n=16 participants at risk
number of adverse events following placebo in the armodafniil then placebo condition.
|
|---|---|---|---|---|
|
Nervous system disorders
sleep difficulties
|
5.9%
1/17 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/17
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60