Effects of Gilenya (Fingolimod) on Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis (GLT)
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|ClinicalTrials.gov Identifier: NCT02021162|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : April 17, 2019
|Condition or disease|
|Multiple Sclerosis Healthy|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Open-label, Single-blinded, Observational, Prospective, 24-months, Longitudinal, Controlled Study to Assess the Efficacy of Gilenya® on Development of Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||October 2018|
MS patients taking Gilenya
Healthy controls age and gender matched to MS patients taking Gilenya
- Thalamic atrophy [ Time Frame: 6, 12, and 24 months ]To assess the effect of the Gilenya over 6, 12 and 24 months on the evolution of thalamic atrophy in patients with relapsing MS, as measured by change in thalamic volume loss. The changes in thalamic volume over the same time period in HC will be used as a reference.
- Thalamic pathology [ Time Frame: 6, 12, and 24 months ]To examine the effect of the Gilenya over 6, 12 and 24 months on the evolution of thalamic pathology in patients with relapsing MS, as measured by change in MP-LPV. The changes in MP-LPV of the thalamus over same time period in HC will be used as a reference.
- Cognitive impairment [ Time Frame: 12 and 24 months ]To determine the effect of the Gilenya over 12 and 24 months on the evolution of cognitive impairment in patients with relapsing MS, as measured by changes in Minimal Assessment of Cognitive Function (MACFIMS) battery. The cognitive changes over the same time period will be examined in HC, and used as a reference.
- Thalamic volume and accumulation of iron in response to herpes viruses [ Time Frame: 24 months ]To investigate the association between development of thalamus pathology, as defined by changes in thalamic volume loss and accumulation of MP-LPV, development of cognitive impairment, and changes in response to herpes viruses (anti-CMV and anti-EBV) over 24 months of the study.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021162
|United States, New York|
|Buffalo Neuroimaging Analysis Center|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Robert Zivadinov, MD, PhD||SUNY University at Buffalo|