CompletedNot a drug-phase studyRelapsing MSNCT05783934

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • 18F-florbetaben PET/CT

What it measured

Main measures

  • PET outcome

    this evaluation is performed at the time of recruitment

    Myelin repair

Other measures (1)

  • correlation between PET data and MRI images and degree of disability

    this evaluation is performed at the time of recruitment

    MRI lesionsBrain volume lossSmouldering inflammationBlood or spinal fluid markersMyelin repairImmune response

Who could take part

Relapsing MS · 18 to 99

Inclusion Criteria: * progressive stage of multiple sclerosis (both secondary and primary, SMP) * patients in relapsing-remitting multiple sclerosis (RRMS) Exclusion Criteria: * a disability greater than 7 * patients with a cognitive impairment interfering with full study participation (Minimental score less than 24) * patients with internal medical problems that in the opinion of the investigator may interfere with full participation and collaboration * inability to undergo MRI or PET examinations * ongoing pregnancy and lactation

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The goal of this clinical trial study is to evaluate the presence of relationships between PET and MRI images indicative of chronic inflammatory activity (smoldering plaques), apparent absence of inflammatory activity (silent plaques without microglial rim), or indicative of more recent inflammatory activity, in contrast-enhanced areas or in T2/Flair-positive areas of not distant onset in patients diagnosed with progressive (secondary or primary) stage multiple sclerosis and in patients in relapse and remission. Laboratory analysis of serum markers will be performed: neuronal and glial cytoskeletal proteins (e.g., Nf-L, pN-FH, GFAP), and the levels of neurotrophic factors (e.g., BDNF, GDNF) and cytokines (e.g., TNFα, IL-6, IL-1β, interferon) will be evaluated.

Papers

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History

    1. Started

      Jul 2021

    2. Main results due

      Nov 2023

    3. Finished

      Jan 2024

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