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

NCT02651545 | Completed Results

• 1 other identifier: 1116240
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (6)

• Expanded Disability Status Scale Score (EDSS)

  The Expanded Disability Status Scale (EDSS). 0-10 scale with higher scores indicating more severe disability.

  0, 12, and 24 months

• Timed 25-foot Walk.

  Time it takes in seconds for patient to walk 25 feet. Higher times indicate slower ambulation.

  0, 12, and 24 months

• Nine-hole Peg Test

  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.

  0, 12, and 24 months

• California Verbal Learning Test 2nd Edition Total Learning Score

  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.

  0, 12, and 24 months

• Brief Visuospatial Memory Test Revised Total Learning Score

  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.

  0, 12, and 24 months

• Symbol Digit Modalities Test Total Correct

  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.

  0, 12, and 24 months

Secondary Outcomes (1)

• Change in Vocational Status

  0, 12, and 24 months

Study Arms (2)

Relapsing MS patients

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

Healthy Controls

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A sample of 30 relapsing MS patients new to teriflunomide therapy will be enrolled. A sample 30 healthy control volunteers, matched on demographics with the treated group will be enrolled.

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)

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Buffalo General Hospital, D3

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Michael Jaworski
• Organization: UBMD Neurology

mgjawors@buffalo.edu

716-323-0550

Study Officials

• Ralph HB Benedict, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: January 11, 2016
• Study Start: February 1, 2014
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Locations

US (1)