Running, not recruitingPhase 4Progressive MSNCT033686772016-003622-16

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Change of 11C-PK11195-radioligand binding using PET

    0 to 12 months

    Smouldering inflammation
  • Change in microglia-activity in RRMS patients on teriflunomide treatment as measured by PET imaging and [11C]PK11195 radioligand.

    Smouldering inflammation

Other measures (4)

  • MRI metrics

    0, 12 months, 24 months, 36 months

    MRI lesions
  • EDSS

    0, 12 months, 24 months, 36 months

    Disability progression
  • BICAMS

    0, 36 months

    Thinking and memory
  • Comparison of the following MRI parameters

    MRI lesions

Who could take part

Progressive MS · 40 to 55

Inclusion Criteria: * Signing the consent form * Having used teriflunomide treatment for at least 6 months * 40-55 years of age at the time of signing the research consent form * MS diagnosis in accordance with either the Poser or McDonald criteria * EDSS 2-6.5 * Clear lesion load in brain MRI (> 9 T2 lesion) Exclusion Criteria: * Patients suffering from another brain disease of 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 * Severe hepatic impairment * Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and thereafter as long as its plasma levels are above 0.02 mg/l.

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 teriflunomide treatment on microglial activation in late stage multiple sclerosis.

Papers

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Related trials

History

  1. Phase changed from Not recorded to phase4
  1. Started

    Dec 2017

  2. Main results due

    Jun 2027

  3. Finished

    Dec 2027

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