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

University at Buffalo (UB)

Status

Completed

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT02651545

1116240

Details and patient eligibility

About

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.

Full description

Summary:

Objectives: The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on cognitive abilities in patients with relapsing multiple sclerosis (MS). There are two secondary objectives, to [a] relate changes in cognition to vocational problems, and [b] determine MRI correlates of change in cognition, more specifically gray-matter (GM) volume metrics which the investigators believe reflect neurodegeneration.

Design: This is a prospective, observational, single-blinded, longitudinal study of teriflunomide effects on cognitive performance in MS patients over 24 months. Neuropsychological status and 3T (3 Tesla) MRI will be assessed at baseline, 12 months and 24 months. Vocational status will be assessed every three months via the internet. Statistical analysis will emphasize within-subjects changes in all metrics to maximize statistical power.

Study Population: Thirty (30) relapsing MS patients and 30 healthy controls (HC) will be enrolled in the study.

Outcomes: An information processing speed index and a memory composite index will be calculated from conventional, validated neuropsychological tests as recommended by consensus opinion publications. Conventional clinical metrics for overall neurological disability will also be assessed. Vocational performance will be monitored using a newly developed online survey called the Multiple Sclerosis Vocational Monitoring Survey (MSVMS). Regional GM atrophy, as defined by measurement of thalamic and cortical atrophy, will serve as neurodegeneration outcomes.

Significance of the research: The effect of teriflunomide on the development of cognitive impairment and vocational capacity is unknown. This study will elucidate the effect of teriflunomide on these important outcomes.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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 <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

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