CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Anakinradrug
Likely dose
Anakinra 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04025554
NCT04025554Phase 2Completed

Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Jul 19, 2019·Updated Dec 27, 2024

In Brief

A Phase 2 clinical trial evaluating Anakinra for Multiple Sclerosis. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartOct 25, 2019
Primary CompletionOct 24, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.0 years ago

Interventions

Anakinradrug

100 mg daily weeks 1-4, 200 mg daily weeks 5-8, 300 mg daily weeks 9-12.