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Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)
CompletedProgressive MSNCT04593927

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 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Siponimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

What it measured

Main measures

  • Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions

    24 months

    Safety

Other measures (5)

  • Physician's Global Assessment (PGA) of disease activity

    month 12 and month 24

  • Changes over time in Expanded Disability Status Scale (EDSS) score

    Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24

    Disability progression

  • Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS

    24 months

    Disability progression

  • Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS

    24 months

    Disability progression

  • Annual relapse rate

    24 months

    Relapses

Who could take part

Progressive MS · Up to 99

Inclusion Criteria: * Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis Exclusion Criteria: -

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

About this trial

In the sponsor's words

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

Papers

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    Related trials

    History

      1. Started

        Oct 2020

      2. Main results due

        Aug 2023

      3. Finished

        Aug 2023

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