Running, not recruitingPhase 4Relapsing MSNCT042398202024-519921-39-002019-001960-31

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • 11C-PK11195 binding in MS patient brain

    baseline, 18 months

    Smouldering inflammation
  • Change in TSPO binding in the NAWM after 18 months of cladribine treatment, measured with distribution volume ratio (DVR) of the 11C-PK11195 radioligand binding

    Smouldering inflammation
  • Change in microglial cell activation in different brain areas (NAWM normal appearing grey matter and the chronic active/ smoldering (slowly expanding) lesions) before and after 18 months of treatment with cladribine evaluated with [11C]PK11195-PET-imaging.

    MRI lesionsSmouldering inflammation

Other measures (15)

  • MRI metrics

    Baseline, 18 months

    MRI lesions
  • Expanded Disability Status Scale

    Baseline, 18 months

    Disability progression
  • Multiple Sclerosis Composite Score

    Baseline, 18 months

    Thinking and memoryWalking and mobilityArm and hand function
  • Blood biomarkers

    Baseline, 18 months

    Blood or spinal fluid markers
  • 11C-PK11195 difference in RRMS and historical healthy controls

    Baseline, 18 months

    Smouldering inflammation
  • QSM-signal in MS patient brain

    baseline, 18 months

    MRI lesionsSmouldering inflammation
  • Change in TSPO binding in other brain areas of interest after 18 months of cladribine treatment

    Smouldering inflammation
  • Change in microglial cell activation in different brain areas (normal appearing white matter (NAWM), normal appearing grey matter (NAGM) and the chronic active/ smoldering lesions) before and after 18 months of treatment with cladribine evaluated with QSM-MRI.

    MRI lesionsSmouldering inflammation
  • Change in the total lesion load of the white matter MS plaques at different time points using MRI

    MRI lesions
  • Change in total brain, white matter (WM) and gray matter (GM) volumes using MRI at different time points of the study

    MRI lesions

Who could take part

Relapsing MS · 45 to 55

Inclusion Criteria: * Signing the informed consent form * Cladribine treatment is planned and indicated and is according to label * 45-55 years of age at the time of signing the research informed consent form * RRMS diagnosis in accordance with McDonald 2017 criteria Exclusion Criteria: * Patients with other neurodegenerative disease than MS * Abnormal lymphocyte counts * Patients with human immunodeficiency virus (HIV). * Patients with active chronic infection (tuberculosis or hepatitis). * Patients with active malignancy. * Patients with moderate or severe renal impairment (creatinine clearance \<60 mL/min) * Patients that are pregnant or breast-feeding * Corticosteroid treatment within 4 weeks of imaging * Patients with significant abnormal findings other than MS in the screening MRI. * Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging) * Contraindication to PET scan investigations * Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study. * Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans. * Patients with previous alemtuzumab administration * Patients with less than 6 months since previous administration of ocrelizumab or rituximab (or with abnormal B-cell counts) * Patients with less than 1 month since previous administration of other disease modifying therapy

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

About this trial

In the sponsor's words

To evaluate the effect of cladribine treatment on microglial activation with conventional MRI, QSM-post processing and TSPO-PET imaging in late stage relapsing remitting multiple sclerosis patients.

Papers

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Related trials

History

    1. Started

      Jan 2020

    2. Main results due

      Feb 2024

    3. Finished

      Dec 2025

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