Natalizumab and Chronic Inflammation
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor declined further support
What was tested
Treatment tested
- Natalizumab 300 MG in 15 ML Injection
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Treatment Single Arm | 1 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans
12 months
MRI lesions
Other measures (1)
Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)
12 months
MRI lesions
Who could take part
MS (type not specified) · 18 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
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History
Started
Sept 2022
Main results due
Apr 2023
Finished
Apr 2023
Results posted
Apr 2024
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