Natalizumab and Chronic Inflammation

Multiple Sclerosis Clinical Trial

Official title:

Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05177718
• Other study ID #: 201600
• Status: Terminated
• Phase: Phase 4
• Start date: September 16, 2022
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Natalizumab 300 MG in 15 ML Injection
Disease modifying agent

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life	To explore changes in QoL measurements and the relations between these changes and those seen in ktrans and natalizumab serum levels.	12 months
Primary	Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans	To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan	12 months
Secondary	Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)	To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan	12 months