Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-19

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05376579

Active Secondary Progressive Multiple Sclerosis

COMPLETED

Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients

NCT03623243

Multiple Sclerosis Relapsing Multiple Sclerosis Advancing Multiple Sclerosis

COMPLETED PHASE3

A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis

NCT06395909

Relapsing Multiple Sclerosis Clinically Isolated Syndrome Relapsing Remitting Multiple Sclerosis +1 more

COMPLETED

Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis

NCT04925557

Secondary-progressive Multiple Sclerosis

TERMINATED PHASE2/PHASE3

Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo

NCT05826028

Secondary Progressive Multiple Sclerosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary data will be collected during an observational period of three years of Siponimod treatment. Additionally, medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of Siponimod treatment effects on an individual basis. It is planned to include an optional blood draw for a later biomarker analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Siponimod

Patients administered Siponimod as per Swiss label

Siponimod

Intervention Type OTHER

Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod as by swiss label, that have started before inclusion of the patient into the study will be enrolled.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Siponimod

Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod as by swiss label, that have started before inclusion of the patient into the study will be enrolled.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No