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ITASIA

Impact of Mayzent (Siponimod) on Active Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study in Italy
CompletedProgressive MSNCT05376579

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 15 months 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

  • Proportion of patients with six-month CDP during 36 months of treatment

    36 months

    Disability progressionThinking and memory

Other measures (19)

  • Annualized relapse rate (ARR)

    Month 12, month 24 and month 36

    Relapses

  • Number of new/newly enlarging T2 [neT2] and Gd+T1 lesions

    Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

    MRI lesions

  • Expanded Disability Status Scale scores

    Month 12, month 24 and month 36

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

  • Expanded Disability Status Scale trend

    Month 12, month 24 and month 36

    Disability progression

  • Proportion of patients with No Evidence of Disease Activity (NEDA)-3

    Month 12, month 24 and month 36

    Disability progressionRelapsesMRI lesions

  • UK Neurological Disability Scale (UKNDS)

    Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

    VisionFatigueWalking and mobilityArm and hand functionBladder, bowel and sexual functionPainMood and sleep

  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

    Thinking and memoryFatigue

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

    Mood and sleep

  • Symbol Digit Modality test (SDMT)

    Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

    Thinking and memory

  • Clinical Global Impression (CGI)

    Baseline, month 3, month 6, month 12, month 18, month 24, month 30 and month 36

Who could take part

Progressive MS · 18 to 60

Inclusion Criteria: 1. Signed informed consent: patient must provide written informed consent before any study assessment is performed. 2. Male/female participants aged between 18 and 60. 3. Documented diagnosis of active SPMS. 4. Siponimod treatment as routine medical care: patients newly treated with siponimod (starting not more than 7 days before baseline visit), for whom the decision to start treatment has already been taken independently of study inclusion based on clinical practice and according to SmPC and AIFA criteria, and who successfully qualified for treatment with siponimod (i.e. passed the screening procedure mandated by the SmPC and Risk Management Plan (RMP) for this treatment, including genotyping for CYP2C9 to determine CYP2C9 metaboliser status). Exclusion Criteria: 1. Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC. 2. Pregnant or lactating women. 3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the investigator's judgement. 4. Current participation in an interventional trial. 5. Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).

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

About this trial

In the sponsor's words

This is an observational, multicenter, single-arm, prospective study conducted in Italy

Papers

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    Related trials

    History

      1. Started

        Jun 2022

      2. Main results due

        Jul 2025

      3. Finished

        Jul 2025

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