Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design

Completed

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

This study will observe participants with relapsing remitting multiple sclerosis who are switching therapies from natalizumab to dimethyl fumarate to determine disease stability.

Key facts

Study ID

NCT01945359

Run by

Rocky Mountain MS Research Group, LLC

People needed

30

Starts

2013-09-01

Expected to finish

2015-06-01

Last updated by the study team

2015-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• JCV Indec of 1.5 of greater and currently receiving natalizumab therapy for at least 24 months
• Decision to treat with DMF must precede enrollment
• Ability to understand the purpose and risk of the study and provide authorization for the use of protected health information in accordance with the monitoring agency
• Men or women >= 18 years at time of informed consent
• Naive to DMF or fumaric acid esters
• Confirmed diagnosis of a relapsing form of MS as verified by their treating physician

You may not qualify if…

• Inability ot comply with study requirements as outlined in the informed consent
• Known active malignancies or any other major co morbidity that, in the opinion of the Investigator, would affect the outcome of the study
• Pregnancy or breastfeeding
• Previous treatment with dimethyl fumarate

Where it is running

• Rocky Mountain MS Research Group — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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