Natalizumab and Chronic Inflammation

NCT05177718 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 201600
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, MRI, blood brain barrier, myelin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)

  12 months

Other Outcomes (1)

• Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life

  12 months

Study Arms (1)

Treatment Single Arm

OTHER

SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV

Drug: Natalizumab 300 MG in 15 ML Injection

Interventions

Natalizumab 300 MG in 15 ML Injection DRUG

Disease modifying agent

Treatment Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• multiple sclerosis
• clinical eligibility to treatment with Natalizumab
• no previous exposure to Natalizumab treatment

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Biogen: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab; Injections

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Natalizumab and chronic Blood Brain Barrier Breakdown
• Organization: Vumc

francesca.r.bagnato@VUMC.ORG

6159360060

Study Officials

• Francesca Bagnato, MDPhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open-label, prospective longitudinal study.

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 5, 2022
• Study Start: September 16, 2022
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: \[per PDBP policy\]
• Access Criteria: \[per PDBP policy\]

Locations

US (1)