Natalizumab and Chronic Inflammation

Phase 4

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Natalizumab 300 MG in 15 ML Injection

• Registration Number: NCT05177718
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).

Detailed Description

The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity.

As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-05
• Study Start: 2022-09-16
• Primary Completion: 2023-04-05
• Study Completion: 2023-04-05
• Results First Submitted: 2024-03-11
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Results First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. multiple sclerosis
2. clinical eligibility to treatment with Natalizumab
3. no previous exposure to Natalizumab treatment

Exclusion Criteria

1. inability to perform an MRI with contrast
2. inability to undergo a paper-pencil questionnaires and blood work

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Single Arm	Natalizumab 300 MG in 15 ML Injection	SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV

Primary Outcome Measures

Name	Time	Method
Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans	12 months	To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Secondary Outcome Measures

Name	Time	Method
Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)	12 months	To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States