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Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy

NCT ID: NCT05376579

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-17

Study Completion Date

2025-07-22

Brief Summary

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

Detailed Description

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Primary data will be collected over a period of three years. Medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of the effects of siponimod treatment on an individual basis.

Conditions

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Active Secondary Progressive Multiple Sclerosis

Keywords

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Secondary Progressive Multiple Sclerosis aSPMS NIS Italy Mayzent siponimod

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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siponimod

patients treated with siponimod

siponimod

Intervention Type OTHER

Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study after the independent decision by physician and patient to start siponimod treatment as routine clinical care.

Interventions

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siponimod

Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study after the independent decision by physician and patient to start siponimod treatment as routine clinical care.

Intervention Type OTHER

Other Intervention Names

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mayzent

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Ancona, AN, Italy

Site Status

Novartis Investigative Site

L’Aquila, AQ, Italy

Site Status

Novartis Investigative Site

Bergamo, BG, Italy

Site Status

Novartis Investigative Site

Bologna, BO, Italy

Site Status

Novartis Investigative Site

Brescia, BS, Italy

Site Status

Novartis Investigative Site

Como, CO, Italy

Site Status

Novartis Investigative Site

Catanzaro, CZ, Italy

Site Status

Novartis Investigative Site

Foggia, FG, Italy

Site Status

Novartis Investigative Site

Genova, GE, Italy

Site Status

Novartis Investigative Site

Messina, ME, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Palermo, PA, Italy

Site Status

Novartis Investigative Site

Padua, PD, Italy

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Pavia, PV, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Orbassano, TO, Italy

Site Status

Novartis Investigative Site

Trieste, TS, Italy

Site Status

Novartis Investigative Site

Vicenza, VI, Italy

Site Status

Novartis Investigative Site

Napoli, , Italy

Site Status

Novartis Investigative Site

Napoli, , Italy

Site Status

Novartis Investigative Site

Novara, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CBAF312AIT04

Identifier Type: -

Identifier Source: org_study_id