NCT05376579Completed
Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy
Impact of Mayzent (Siponimod) on Active Secondary Progressive Multiple Sclerosis Patients in a Long-term Non-interventional Study in Italy
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
This is an observational, multicenter, single-arm, prospective study conducted in Italy
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 134 (actual)
- First submitted
- 12 May 2022
- Start date
- 17 Jun 2022
- Primary completion date
- 22 Jul 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT05376579
What you commit to
- Study type: Observational
- Participants enrolled: 134
- From 17 Jun 2022 to the primary completion date, 22 Jul 2025
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).
Other illness
- 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.
Other
- Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC.
- Pregnant or lactating women.
- Current participation in an interventional trial.
Who the study is looking for
- Signed informed consent: patient must provide written informed consent before any study assessment is performed.
- Male/female participants aged between 18 and 60.
- Documented diagnosis of active SPMS.
- 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).
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.