- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02651545
Effects of Teriflunomide (Aubagio) on Cognitive and Vocational Outcomes in Multiple Sclerosis
Teriflunomide (Aubagio) Effects on Cognitive and Vocational Outcomes, as Related to Neurodegeneration in Multiple Sclerosis: A Prospective, Observational, Single-blinded Study.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14203
- Buffalo General Hospital, D3
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Relapsing MS patients
Thirty (30) relapsing MS patients new to teriflunomide therapy will be enrolled.
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Healthy Controls
A sample of 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expanded Disability Status Scale Score (EDSS)
Time Frame: 0, 12, and 24 months
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The Expanded Disability Status Scale (EDSS).
0-10 scale with higher scores indicating more severe disability.
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0, 12, and 24 months
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Timed 25-foot Walk.
Time Frame: 0, 12, and 24 months
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Time it takes in seconds for patient to walk 25 feet.
Higher times indicate slower ambulation.
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0, 12, and 24 months
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Nine-hole Peg Test
Time Frame: 0, 12, and 24 months
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The 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.
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0, 12, and 24 months
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California Verbal Learning Test 2nd Edition Total Learning Score
Time Frame: 0, 12, and 24 months
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A 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.
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0, 12, and 24 months
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Brief Visuospatial Memory Test Revised Total Learning Score
Time Frame: 0, 12, and 24 months
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A 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.
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0, 12, and 24 months
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Symbol Digit Modalities Test Total Correct
Time Frame: 0, 12, and 24 months
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A 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.
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0, 12, and 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vocational Status
Time Frame: 0, 12, and 24 months
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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.
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0, 12, and 24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Ralph HB Benedict, PhD, State University of New York at Buffalo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1116240
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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