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SWISSMASIA

Swiss Study of the Impact of Mayzent (Siponimod) on Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study
Stopped earlyProgressive MSNCT04895202

What it found

Stopped early

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

Reason given: Insufficient patient recruitment

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

What it measured

Main measures

  • Change of expanded disability status scale (EDSS)

    Baseline, month 36

    Disability progressionVisionThinking and memoryFatigueArm and hand functionBladder, bowel and sexual functionMood and sleep

Other measures (7)

  • Proportion of patients with six month confirmed disability progression (CDP) by expanded disability status scale (EDSS)

    month 36

    Disability progressionRelapses

  • Proportion of patients with six month confirmed disease progression by symbol digit modalities test (SDMT)

    Up to 36 months

    Thinking and memoryPhysical function

  • Treatment effect of Siponimod on walking speed as measured by the timed 25 foot walk test (T25FWT)

    Baseline, up to 36 months

    Disability progressionWalking and mobility

  • Treatment effect of Siponimod on quality of life based on EQ-5D

    Baseline, month 36

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Treatment effect of Siponimod on fatigue measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Baseline, month 36

    Thinking and memoryFatigue

  • Treatment effect of Siponimod on fatigue measured by Beck's depression inventory (BDI)

    Baseline, month 36

    FatigueMood and sleep

  • Treatment effect of Siponimod on fatigue measured by Epworth sleepiness scale (ESS) questionnaire

    Baseline, month 36

    FatigueMood and sleep

Who could take part

Progressive MS · 18 and over

Inclusion Criteria: 1. Signed informed consent 2. Adult patients with a documented diagnosis of SPMS with inflammatory disease activity who are going to be treated with Siponimod under routine medical care and in accordance with the Swiss label 3. Patient willing and able to complete the questionnaires Exclusion Criteria: 1. Patients treated outside of the approved Swiss label for Siponimod 2. Prior treatment or already ongoing treatment with Siponimod 3. Use of investigational drugs during the study, OR within 3 months before enrollment, OR within 5 half-lives of investigational drug before enrollment, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer 4. Subjects who are not able to provide consent due to incapable judgement

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 national, prospective, multicenter, non-interventional (observational) study with the aim to describe the impact of Siponimod treatment in a real-world SPMS population in Switzerland who are treated with Siponimod as per Swiss label.

Papers

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    Related trials

    History

      1. Started

        Nov 2021

      2. Main results due

        Dec 2022

      3. Finished

        Dec 2022

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