Tecfidera Diffusion Tensor Imaging

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2016
• Main ID: NCT02686684
• Date of registration: 11/02/2016
• Prospective Registration: No
• Primary sponsor: University at Buffalo
• Public title: Tecfidera Diffusion Tensor Imaging DTI
• Scientific title: An Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple Sclerosis
• Date of first enrolment: November 2015
• Target sample size: 115
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02686684
• Study type: Observational
• Study design: Observational Model: Case Control
• Phase: N/A

Contacts

• Name: Robert Zivadinov, MD, PhD
• Affiliation: BNAC

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- None of the exclusion criteria

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: Dimethyl fumarate

Primary Outcome(s)

Change in thalamus pathology as measured by FIRST analysis [Time Frame: Change between baseline and 24 months]

Secondary Outcome(s)

Change in normal appearing white matter (NAWM) pathology as measured by SIENAX v2.6 [Time Frame: Change between baseline and 24 months]

Secondary ID(s)

T-DTI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors