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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
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Brief Summary:
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.

Condition or disease
Multiple Sclerosis Healthy

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Gilenya
MS patients taking Gilenya
Healthy Controls
Healthy controls age and gender matched to MS patients taking Gilenya



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 relapsing MS patients naïve to Gilenya who fulfill the inclusion and exclusion criteria used for screening and start Gilenya, on a clinical basis will be enrolled in the study. In addition, 20 healthy controls will be included as a reference population. The plan is to recruit the 50 subjects (30 relapsing MS and 20 healthy controls) at a single center.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
Novartis
Investigators
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Principal Investigator: Robert Zivadinov, MD, PhD SUNY University at Buffalo
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Responsible Party: Robert Zivadinov, MD, PhD, Director, Buffalo Neuroimaging Analysis Center, Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT02021162    
Other Study ID Numbers: Gilenya-thalamus
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
Multiple sclerosis
Gilenya
Healthy controls
Thalamic atrophy
MRI
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders