Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
Background:
Multiple sclerosis (MS) is a disease of the central nervous system (CNS). People who have MS
may have lesions that form on parts of the CNS, such as the brain. Some of these lesions may
be inflamed for a long time. This causes MS to progress. There is no treatment for these
lesions. Researchers believe that a drug that decreases inflammation can help.
Objective:
To see if a drug called anakinra can help clear inflammation in MS brain lesions.
Eligibility:
People 18 and older with MS and at least one white matter lesion.
Design:
Participants will be screened with one or more Neuroimmunology Clinic protocols.
Participants will have a medical history and physical exam. They will have blood and urine
tests. They will have a lumbar puncture. For this, a needle is inserted between the bones in
the back, and cerebrospinal fluid is removed. They will also have an MRI of the brain. The
MRI scanner is a cylinder surrounded by a strong magnetic field. Participants will lie on a
table that slides in and out of the scanner.
Participants will repeat the above procedures throughout the study.
Participants will get their first dose of anakinra at the clinic. They will administer the
rest of the doses themselves, by injection under the skin.
Participants will track their daily dosage electronically or in a written drug diary.
Participants will have 4 visits while taking the drug. At each visit, sharps boxes and empty
vials will be collected.
Participants will have 2 follow-up visits after completing treatment.
The study will last 28 weeks.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)