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

NCT ID: NCT02651545

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2020-11-30

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Relapsing MS patients

Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.

No interventions assigned to this group

Healthy Controls

A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.

No interventions assigned to this group

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 <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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Ralph H.B. Benedict

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph HB Benedict, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

Buffalo General Hospital, D3

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1116240

Identifier Type: -

Identifier Source: org_study_id