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

NCT02021162 | Completed

• 1 other identifier: Gilenya-thalamus
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Healthy

Keywords

Multiple sclerosis; Gilenya; Healthy controls; Thalamic atrophy; MRI

Outcome Measures

Primary Outcomes (1)

• Thalamic atrophy

  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.

  6, 12, and 24 months

Secondary Outcomes (3)

• Thalamic pathology

  6, 12, and 24 months

• Cognitive impairment

  12 and 24 months

• Thalamic volume and accumulation of iron in response to herpes viruses

  24 months

Study Arms (2)

Gilenya

MS patients taking Gilenya

Healthy Controls

Healthy controls age and gender matched to MS patients taking Gilenya

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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

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

Sponsors & Collaborators

• University at Buffalo: lead
• Novartis: collaborator

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

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

Study Officials

• Robert Zivadinov, MD, PhD

  SUNY University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 27, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)