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Monoclonal Antibodies

Natalizumab for Multiple Sclerosis

Phase 4
Recruiting
Led By Francesca Bagnato, MDPhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No previous exposure to Natalizumab treatment
Diagnosis of multiple sclerosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test if Natalizumab can help to restore and repair the blood brain barrier in people with multiple sclerosis.

Who is the study for?
This trial is for individuals with multiple sclerosis who are clinically eligible to start treatment with Natalizumab and have never been treated with it before. Participants must be able to undergo MRI scans with contrast, complete questionnaires, and provide blood samples.Check my eligibility
What is being tested?
The study is testing the effectiveness of Natalizumab injections in treating MS by repairing the blood brain barrier (BBB) integrity and addressing its subtle leakages.See study design
What are the potential side effects?
Natalizumab may cause side effects such as increased risk of infection, allergic reactions during infusion, liver damage, or a rare but serious brain infection called PML (progressive multifocal leukoencephalopathy).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never been treated with Natalizumab.
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I have been diagnosed with multiple sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of Natalizumab on magnetic resonance imaging measures of blood brain barrier permeability: K-trans
Secondary outcome measures
Effect of Natalizumab on magnetic resonance imaging measures of myelin integrity: pool saturation ratio (PSR)
Other outcome measures
Effect of Natalizumab on questionnaire derived measures of Quality of Life

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment Single ArmExperimental Treatment1 Intervention
SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,156 Total Patients Enrolled
BiogenIndustry Sponsor
639 Previous Clinical Trials
467,321 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
142,217 Patients Enrolled for Multiple Sclerosis
Francesca Bagnato, MDPhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Natalizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05177718 — Phase 4
Multiple Sclerosis Research Study Groups: Treatment Single Arm
Multiple Sclerosis Clinical Trial 2023: Natalizumab Highlights & Side Effects. Trial Name: NCT05177718 — Phase 4
Natalizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05177718 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has recruitment for this medical study been successful?

"Affirmative, clinicaltrials.gov indicates that this study launched on September 16th and was most recently updated two days later. The trial requires 36 volunteers from a single medical site."

Answered by AI

Are participants being accepted for the current iteration of this trial?

"Affirmative. Information available on clinicaltrials.gov confirms that this medical experiment, initially published on September 16th 2022, is actively looking for participants. The study requires 36 volunteers to be enrolled at a single site."

Answered by AI

Is this treatment method reliable and secure for individuals?

"A score of 3 was assigned to this treatment's safety, as it has been approved by the FDA and is in its fourth phase of trials."

Answered by AI

Does the trial's eligibility criteria encompass individuals over 80?

"This clinical trial is seeking individuals aged 18 to 65. There are 43 trials targeting minors and 391 for those over the age of retirement."

Answered by AI

Is there an opportunity for me to volunteer in this research endeavor?

"This medical trial is currently enrolling 36 individuals, aged 18-65 years old and afflicted with multiple sclerosis. To be eligible for this study, participants must not have had prior exposure to Natalizumab treatment."

Answered by AI
~11 spots leftby Dec 2024