MSFrontier

CLADRI_NET

A phase IV, unicentric, open label clinical trial to evaluate the default mode network in multiple sclerosis patients on Cladribine treatment.
WithdrawnPhase 4MS (type not specified)2023-504577-21-00

What it found

Stopped early

The trial ended early for another reason (see below).

What was tested

Treatment tested

What it measured

Main measures

  • Changes in resting state functional activity indexes (rs-fMRI) at 18 months compared to baseline

    Nerve conduction tests

Other measures (9)

  • Changes in resting state functional activity indexes (rs-fMRI) after 18 months of cladribine treatment

    Nerve conduction tests

  • Changes in Image Tensor Diffusion of main cerebral tracts after 18 months of cladribine treatment.

    MRI lesions

  • Changes in volumetric measures from key brain region (corpus callosum, thalamus and hippocampus) after 18 months of cladribine treatment

  • The contribution of cortico-cerebellar connectivity to MS cognitive performance after 18 months of cladribine treatment

    Thinking and memoryNerve conduction tests

  • Changes in cortical Atrophy Index after 18 months of cladribine treatment after 18 months of cladribine treatment.

    Brain volume loss

  • Changes in Brain Activity during processing speed task after 18 months of cladribine treatment.

    Thinking and memory

  • Changes in cognitive functioning indexes measured with neuropsychological tests after 18 months of cladribine treatment.

    Thinking and memory

  • Changes in emotional/behavioural indexes measured with neuropsychological tests after 18 months of cladribine treatment.

  • Changes in clinical neurological status measured with EDSS and ARR after 18 months of cladribine treatment.

    Disability progressionRelapses

Who could take part

MS (type not specified) · 18 to 64

Inclusion: - MS diagnostic following McDonald 2010 diagnosis criteria. - Age between 30 and 55 years old. - MS patients that started treatment with cladribine tablets in the last month. - Consent form signature Exclusion: - Dementia diagnosis, following Spanish Neurological Society criteria. - Mayor psychiatric illness. - Physical or intellectual limitations to successfully perform neuropsychological evaluation. - Any other circumstance that may interfere with functional magnetic resonance session - Abnormal renal function previous to MRI session. - Pregnant or breastfeeding females or males and females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until six months after the end of the treatment

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

About this trial

In the sponsor's words

To study the changes in functional connectivity by DMN´s degree of activation in MS patients with cladribine tablets.

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Related trials

History

    1. Started

      Jun 2023

    2. Finished

      Dec 2025

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