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Gilenya's Impact on Cognitive Function and Thalamic Volumes

NCT03243721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-05

No results posted yet for this study

Summary

This evaluation will be a one-year feasibility study to characterize the neuroprotective benefits of Gilenya and its effects on cognition and grey matter volumes. The study will enroll 15 patients with relapsing-remitting multiple sclerosis being treated with Gilenya and 5 healthy controls. Each participant will undergo a battery of neurometric testing at baseline, six months, and one year. In addition, patients will undergo high-field 7T MRI at the same time points.

Conditions

Interventions

DIAGNOSTIC_TEST

7T MRI

A high field MRI that will take approximately one hour.

DIAGNOSTIC_TEST

Neurocognitive testing

A series of tests to assess memory, verbal skills, and visuospatial skills.

Sponsors & Collaborators

Principal Investigators

  • Devon S Conway, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2019-11-12
Completion
2019-11-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243721 on ClinicalTrials.gov