Running, not recruitingRelapsing and progressiveNCT04126772

What it found

Still running

No result yet.

What it measured

Main measures

  • 11C-PK11195 binding in MS patient brain

    Baseline, 4 months 18 months

    Smouldering inflammation
  • 11C-SMW139 binding in MS patient brain

    Baseline, 4 months 18 months

    Smouldering inflammation
  • QSM-signal in MS patient brain

    Baseline, 4 months 18 months

    MRI lesionsSmouldering inflammation

Other measures (8)

  • 11C-PK11195 binding in healthy control brain

    Baseline

    Smouldering inflammation
  • 11C-SMW139 binding in healthy control brain

    Baseline

    Smouldering inflammation
  • QSM-signal in healthy control brain

    Baseline

    MRI lesionsSmouldering inflammation
  • MRI metrics

    Baseline, 4 months, 18 months

    MRI lesions
  • EDSS

    Baseline, 4 months, 18 months

    Disability progression
  • MSFC

    Baseline, 4 months, 18 months

    Disability progressionThinking and memoryWalking and mobilityArm and hand function
  • Fatigue severity scale

    Baseline, 4 months, 18 months

    Fatigue
  • Modified Fatigue Impact Scale

    Baseline, 4 months, 18 months

    Fatigue

Who could take part

Relapsing and progressive · 18 to 70

Inclusion Criteria Active MS-patients: * Informed consent form * At least one 0,5 cm diameter active gadolinium enhancing lesion detected lately * Diagnosed MS-disease according to McDonald criteria SPMS patients * Informed consent form * Diagnosed MS-disease according to McDonald criteria * SPMS disease Healthy controls: * Informed consent form * healthy * age and sex matched with MS-patients in RRMS and SPMS groups Exclusion Criteria MS-patients: * Patients suffering from another brain disease or other autoimmune disease in addition to multiple sclerosis * Steroid treatment 4 weeks prior to the scan * Significant pathology in the MRI scan other than MS-related lesions * Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan) * Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study * Age over 70 Healthy controls: * autoimmune disease, CNS disease or other serious disease * Steroid treatment 4 weeks prior to the scan or other regular medication * persons suffering from claustrophobia or panic disorder, or persons who have exhibited hypersensitivity of PET markers (practical obstacle to the scan) * Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study * Age over 70

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

About this trial

In the sponsor's words

To evaluate active MS plaque evolution with conventional MRI, QSM-post processing, TSPO-PET imaging and P2X7-PET imaging.

Papers

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History

    1. Started

      Feb 2019

    2. Main results due

      Dec 2025

    3. Finished

      Dec 2025

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