N/A
N=60
Effects of Teriflunomide (Aubagio) on Cognitive and Vocational Outcomes in Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02651545 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Expanded Disability Status Scale Score (EDSS) — 3.0; 3.0; 2.5 EDSS Score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expanded Disability Status Scale Score (EDSS) |
3.0; 3.0; 2.5 | — |
| PRIMARY Timed 25-foot Walk. |
7.3; 4.6; 7.4; 4.9; 6.9; 5.3 | — |
| PRIMARY Nine-hole Peg Test |
25.1; 20.0; 26.7; 19.3; 26.8; 20.1 | — |
| PRIMARY California Verbal Learning Test 2nd Edition Total Learning Score |
50.5; 55.3; 47.8; 54.2; 49.1; 53.1 | — |
| PRIMARY Brief Visuospatial Memory Test Revised Total Learning Score |
20.0; 24.4; 19.0; 23.7; 20.0; 24.9 | — |
| PRIMARY Symbol Digit Modalities Test Total Correct |
49.7; 58.9; 47.3; 57.1; 48.9; 59.6 | — |
| SECONDARY Change in Vocational Status |
14; 30; 16; 0; 7; 21 | — |
Summary
Cognitive impairment is common in MS and has devastating impact on functional activities. There is a great demand for medications that will enhance cognitive capacity in MS patients. The effect of teriflunomide on cognition and vocational capacity is unknown. The investigators will address these questions in a sample of 30 relapsing MS patients treated with teriflunomide. Cognitive impairment will be measured by calculating an information processing speed index and a memory composite index from conventional, validated neuropsychological tests as recommended by consensus opinion publications. Vocational performance will be monitored using a newly developed online survey called the Multiple Sclerosis Vocational Monitoring Survey (MSVMS). This study will elucidate the effect of teriflunomide on these important outcomes.
Eligibility Criteria
Inclusion Criteria
- Patient diagnosed with MS according to McDonald criteria
- Age 18-60
- Have a relapsing disease course
- Have Expanded Disability Status Scale scores of 0-6.5
- Have a disease duration 59)
- None of the exclusion criteria
Exclusion Criteria
- MS patients with hepatic impairment
- Nursing mothers or pregnant women who will need to undergo 12 months follow-up
- Women of childbearing potential not using reliable contraception
- Patients currently treated with teriflunomide
- A clinically significant infectious or neurological (for Healthy Controls only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
- History of neurological disorder other than MS
- History of developmental learning disorder or other developmental anomaly
- History of major depressive disorder, or other psychiatric disorder that could impact cognitive capacity, preceding diagnosis of MS
- Current major depressive episode
- Other pathology related to MRI abnormalities
Data sourced from ClinicalTrials.gov (NCT02651545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.