Trial Outcomes & Findings for Effects of Teriflunomide (Aubagio) on Cognitive and Vocational Outcomes in Multiple Sclerosis (NCT NCT02651545)
NCT ID: NCT02651545
Last Updated: 2021-09-24
Results Overview
The Expanded Disability Status Scale (EDSS). 0-10 scale with higher scores indicating more severe disability.
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
0, 12, and 24 months
Results posted on
2021-09-24
Participant Flow
Participant milestones
| Measure |
Relapsing MS Patients
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
7
|
17
|
|
Overall Study
NOT COMPLETED
|
23
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Teriflunomide (Aubagio) on Cognitive and Vocational Outcomes in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
MS Group
n=30 Participants
Multiple Sclerosis Patients Prescribed Aubagio
|
Healthy Control Group
n=30 Participants
Healthy controls matched to the MS group
|
Total
n=60 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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
49.53 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
47.77 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
48.65 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Symbol Digit Modalities Test Total correct
|
49.7 score on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
58.9 score on a scale
STANDARD_DEVIATION 8.5 • n=7 Participants
|
54.3 score on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 12, and 24 monthsThe Expanded Disability Status Scale (EDSS). 0-10 scale with higher scores indicating more severe disability.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Expanded Disability Status Scale Score (EDSS)
EDSS Score Month 0
|
3.0 EDSS Score
Interval 2.0 to 4.63
|
—
|
|
Expanded Disability Status Scale Score (EDSS)
EDSS Score Month 12
|
3.0 EDSS Score
Interval 2.0 to 4.88
|
—
|
|
Expanded Disability Status Scale Score (EDSS)
EDSS Score Month 24
|
2.5 EDSS Score
Interval 2.0 to 6.0
|
—
|
PRIMARY outcome
Timeframe: 0, 12, and 24 monthsTime it takes in seconds for patient to walk 25 feet. Higher times indicate slower ambulation.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
n=30 Participants
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Timed 25-foot Walk.
Month 0
|
7.3 Seconds
Standard Deviation 3.7
|
4.6 Seconds
Standard Deviation 0.8
|
|
Timed 25-foot Walk.
Month 12
|
7.4 Seconds
Standard Deviation 3.1
|
4.9 Seconds
Standard Deviation 1.2
|
|
Timed 25-foot Walk.
Month 24
|
6.9 Seconds
Standard Deviation 2.6
|
5.3 Seconds
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 0, 12, and 24 monthsThe Nine-Hole Peg test is a measure of manual dexterity, where the time in seconds that it takes for patient to fill pegboard holes with pegs and remove them is recorded. Longer times indicate slower motor ability. The range in seconds to complete the nine-hole peg test ranges from 0-seconds to the ceiling value of 300 seconds.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
n=30 Participants
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Nine-hole Peg Test
Month 0
|
25.1 Seconds
Standard Deviation 6.6
|
20.0 Seconds
Standard Deviation 2.2
|
|
Nine-hole Peg Test
Month 12
|
26.7 Seconds
Standard Deviation 7.5
|
19.3 Seconds
Standard Deviation 2.3
|
|
Nine-hole Peg Test
Month 24
|
26.8 Seconds
Standard Deviation 6.9
|
20.1 Seconds
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 0, 12, and 24 monthsA measure of verbal learning and memory. Patient is read a list of 16 words 5 times and asked to recall the list each time. Score 0-80 with higher scores indicating better performance.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
n=30 Participants
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
California Verbal Learning Test 2nd Edition Total Learning Score
Month 0
|
50.5 score on a scale
Standard Deviation 12.5
|
55.3 score on a scale
Standard Deviation 9.7
|
|
California Verbal Learning Test 2nd Edition Total Learning Score
Month 12
|
47.8 score on a scale
Standard Deviation 16.5
|
54.2 score on a scale
Standard Deviation 8.5
|
|
California Verbal Learning Test 2nd Edition Total Learning Score
Month 24
|
49.1 score on a scale
Standard Deviation 14.6
|
53.1 score on a scale
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: 0, 12, and 24 monthsA measure of visual-spatial learning and memory. Patient is shown a display 3 times and asked to recall figures from the display. Score 0-36 with higher scores indicating better performance.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
n=30 Participants
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Brief Visuospatial Memory Test Revised Total Learning Score
Month 0
|
20.0 score on a scale
Standard Deviation 6.5
|
24.4 score on a scale
Standard Deviation 6.3
|
|
Brief Visuospatial Memory Test Revised Total Learning Score
Month 12
|
19.0 score on a scale
Standard Deviation 7.1
|
23.7 score on a scale
Standard Deviation 7.6
|
|
Brief Visuospatial Memory Test Revised Total Learning Score
Month 24
|
20.0 score on a scale
Standard Deviation 9.3
|
24.9 score on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 0, 12, and 24 monthsA measure of cognitive processing speed. Patient is shown a key with symbol-digit pairings and several rows of symbols with empty boxes beneath them. Patient is asked to respond with the numbers that are paired with each of the symbols as quickly and accurately as they can. Score 0-120 with higher scores indicating better performance.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
n=30 Participants
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Symbol Digit Modalities Test Total Correct
Month 0
|
49.7 score on a scale
Standard Deviation 10.6
|
58.9 score on a scale
Standard Deviation 8.5
|
|
Symbol Digit Modalities Test Total Correct
Month 12
|
47.3 score on a scale
Standard Deviation 12.8
|
57.1 score on a scale
Standard Deviation 11.6
|
|
Symbol Digit Modalities Test Total Correct
Month 24
|
48.9 score on a scale
Standard Deviation 10.1
|
59.6 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 0, 12, and 24 monthsPopulation: Patient discontinuations, withdrawals, and loss-to-follow-ups account for declining numbers in each group as study progressed.
Vocational Status assessed by the Buffalo Vocational Monitoring Survey (BVMS). BVMS includes four sections: \[a\] demographics and disease characteristics, \[b\] self-reported symptom inventories, \[c\] general employment information, and \[d\] work-related problems/accommodations. Vocational status (employed vs. unemployed) will be taken from this survey.
Outcome measures
| Measure |
Relapsing MS Patients
n=30 Participants
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
|
Healthy Controls
n=30 Participants
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
|
|---|---|---|
|
Change in Vocational Status
Month 0 · Employed
|
14 Participants
|
30 Participants
|
|
Change in Vocational Status
Month 0 · Unemployed
|
16 Participants
|
0 Participants
|
|
Change in Vocational Status
Month 12 · Employed
|
7 Participants
|
21 Participants
|
|
Change in Vocational Status
Month 12 · Unemployed
|
9 Participants
|
2 Participants
|
|
Change in Vocational Status
Month 24 · Employed
|
3 Participants
|
16 Participants
|
|
Change in Vocational Status
Month 24 · Unemployed
|
5 Participants
|
1 Participants
|
Adverse Events
MS Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MS Group
n=30 participants at risk
Multiple Sclerosis Patients Prescribed Aubagio
|
Healthy Controls
n=30 participants at risk
This sample 30 healthy control volunteers, matched on demographics with the multiple sclerosis group. This healthy control group was not prescribed Aubagio.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • Number of events 3 • 6 years total of study activity.
|
0.00%
0/30 • 6 years total of study activity.
|
|
General disorders
Minor Hair Loss
|
6.7%
2/30 • Number of events 2 • 6 years total of study activity.
|
0.00%
0/30 • 6 years total of study activity.
|
|
General disorders
Headache
|
3.3%
1/30 • Number of events 1 • 6 years total of study activity.
|
0.00%
0/30 • 6 years total of study activity.
|
|
General disorders
Swelling in legs and feet
|
10.0%
3/30 • Number of events 3 • 6 years total of study activity.
|
0.00%
0/30 • 6 years total of study activity.
|
|
General disorders
Weight gain
|
3.3%
1/30 • Number of events 1 • 6 years total of study activity.
|
0.00%
0/30 • 6 years total of study activity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place