Effects of Teriflunomide (Aubagio) on Cognitive and Vocational Outcomes in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02651545

Run by

State University of New York at Buffalo

People needed

60

Starts

2014-02-01

Expected to finish

2020-11-30

Last updated by the study team

2021-09-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 <20 years
• Treatment naïve to teriflunomide
• Be willing and able to comply with the study procedures for the duration of the trial
• Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study-related activities are carried out
• Normal kidney functioning (creatinine clearance >59)
• None of the exclusion criteria

You may not qualify if…

• 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

Where it is running

• Buffalo General Hospital, D3 — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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