Tecfidera Diffusion Tensor Imaging

NCT02686684 | Completed

• 1 other identifier: T-DTI
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of this study is to explore the effect of dimethyl fumarate on gray matter (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to investigate the effect of dimethyl fumarate on evolution of microstructural changes in normal appearing white matter (NAWM), as measured by DTI.

Conditions

Multiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change in thalamus pathology as measured by FIRST analysis

  Change between baseline and 24 months

Secondary Outcomes (1)

• Change in normal appearing white matter (NAWM) pathology as measured by SIENAX v2.6

  Change between baseline and 24 months

Study Arms (2)

Dimethyl Fumarate

MS patients who started treatment with dimethyl fumarate

Drug: Dimethyl fumarate

Healthy Control

Interventions

Dimethyl fumarate DRUG

Dimethyl Fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seventy-five (75) consecutive relapsing MS patients who started treatment with dimethyl fumarate and 40 healthy controls will be recruited in the study.

You may qualify if:

• MS patients diagnosed with MS according to the McDonald criteria
• MS patients having a relapsing disease course
• Starting treatment with dimethyl fumarate therapy for at least one month
• Having standard of care 1.5T or 3T MRI scan obtained at baseline (time of start of dimethyl fumarate) and at the 12 and 24 months after starting dimethyl fumarate. In case of healthy controls, having 2 MRI scans with a minimum of 24 months apart
• Have DTI sequence at all timepoints
• At least 18 years of age

You may not qualify if:

• Patients who had a relapse within 30 days prior to MRI scan date
• Patients who received steroid treatment within 30 days prior to the MRI scan date
• Women who were pregnant during the time of the retrospective study or are pregnant/lactating at the time of the prospective arm
• All healthy controls will be part of the retrospective arm.

Sponsors & Collaborators

• University at Buffalo: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Robert Zivadinov, MD, PhD

  BNAC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 19, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10