Effects of Gilenya (Fingolimod) on Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis, Healthy

In brief

This study aims to assess the effect of Gilenya on brain pathology and cognitive impairment over 6, 12, and 24 months in patients with relapsing MS using MRI, clinical data, and neurological assessments. Healthy controls will also be followed over 6, 12, and 24 months using the same measures.

Key facts

Study ID

NCT02021162

Run by

University at Buffalo

People needed

50

Starts

2013-11-01

Expected to finish

2018-10-01

Last updated by the study team

2019-04-17

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 or a Healthy Control
• Have EDSS scores 0-6.5
• Have a disease duration <20 years
• Patients who have been clinically cleared and have agreed with their neurologist to begin therapy with Gilenya will be asked to enroll in this prospective study. No drug will be administered as part of this study.
• 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) - patients only
• None of the exclusion criteria

You may not qualify if…

• Have received treatment within 30 days prior to enrollment with steroids or any other concomitant immunomodulatory therapies (e.g., interferon-beta, glatiramer acetate, intravenous immunoglobulin)
• Less than 6 months from the use immunosuppressant agents (e.g. including but not limited to mitoxantrone, cyclophosphamide, azathioprine, methotrexate, CellCept, natalizumab
• Ever use of cladribine, fludarabine, or total body irradiation) alemtuzumab/Campath
• Have received an investigational drug or experimental procedure within the past 30 days
• Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
• Abnormal blood tests (pre-dose assessment as per site procedure for patients considered for Gilenya treatment), including ALT or AST greater than two times the upper limit of normal

Where it is running

• Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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