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Clinical Trial: Biomarker-Guided Combination Therapies for MS

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Details
Type of MS: PRMS|RRMS|SPMS
Treatment mode of action: To prevent disability progression
Number of Subjects: 250
Medication: Pioglitazone, Montelukast, Losartan, Hydroxycholoroquine
Location: Maryland
Institutions: NIH Clinical Center, Bethesda, MD Contact Information
NIH Clinical Center Office of Patient Recruitment
1-800-411-1222
PRPL@cc.nih.gov

Funding:

NIH

Description

In people with MS, brain and cerebrospinal fluid biomarkers indicate inflammation or disease. Researchers at the National Institutes Health (NIH) seek volunteers with MS to see if 4 therapies given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which therapies a person with MS might respond to.

Study volunteers will take one of four medications that are not approved by the U.S. Food and Drug Administration (FDA) for MS. Participants will remain on MS medication while also taking the study medications.

You may be eligible if you are: 
At least 18 years old and diagnosed with MS
Able to stand up and walk a few steps with or without help
Willing to have lumbar punctures (spinal tap)

Study participants will:
Be screened for eligibility and may have lumbar punctures, MRIs, eye exams, and other tests.
Take 1 of the 4 study medications and may be asked to take an additional study medication or switch study medication depending on the response to them.

PLEASE NOTE: study visits to Bethesda are involved every 6 months for at least 4 years. Each visit will last 2-3 days. The amount of visits will depend on response to the study medications. Participants will receive study-related tests, procedures, and medication at no cost. Reimbursement for travel may be available for people who live more than 50 miles from the NIH campus in Bethesda; please contact the site for details.

clinicaltrials.gov identifier: NCT03109288

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