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NCT04025554 · ClinicalTrials.gov registry record · Phase 1
Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04025554 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 8 participants.
The verdict
NCT04025554, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- DRUG Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-10-25 |
| Est. Completion | 2023-10-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04025554
The ClinicalTrials.gov registry entry for NCT04025554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anakinra is the first listed.
NCT04025554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04025554 about?
NCT04025554 is a clinical study titled "Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis". 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. Res...
What is the current status of trial NCT04025554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-10-25. Estimated completion is 2023-10-24.
What interventions are being tested in trial NCT04025554?
The interventions under investigation include: Anakinra (DRUG).
Who is sponsoring clinical trial NCT04025554?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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