Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. (EXCHANGE)
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ClinicalTrials.gov Identifier: NCT03623243 |
Recruitment Status :
Recruiting
First Posted : August 9, 2018
Last Update Posted : March 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis Relapsing Multiple Sclerosis Advancing Multiple Sclerosis | Drug: Siponimod | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Open-label single arm study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study |
Actual Study Start Date : | February 14, 2019 |
Estimated Primary Completion Date : | June 7, 2022 |
Estimated Study Completion Date : | July 8, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Siponimod 2 mg
Siponimod 2mg tablets taken once daily after a 5 day titration
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Drug: Siponimod
Siponimod 2mg tablets taken once daily
Other Name: BAF312 |
- Number of patients with treatment emergent adverse events [ Time Frame: Baseline up to 6 months ]Adverse events considered to be drug related will be collected to assess safety and tolerability at scheduled visits after converting from disease modifying therapies
- Number of patients satisfied with treatment as measured by Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline up to 6 months ]TSQM9 - Treatment Satisfaction Questionnaire for Medication: measures patient satisfaction with the medication in 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.
- Change in Heart Rate from baseline [ Time Frame: Baseline to 6 hours post initial treatment ]Heart rate will be evaluated from the time of initial dose intake until 6 hours post dose intake via heart monitor
- Treatment persistence with Siponimod [ Time Frame: Baseline up to 6 months ]Patient retention will be assessed over the study period. Treatment compliance is defined as being 80% adherent and will be assessed via drug accountability performed at the site.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Signed informed consent.
- Male or female aged 18 to 65 years (inclusive).
- Patients with advancing RMS as defined by the principal investigator.
- Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
- EDSS score of >/= 2.0 to 6.5 (inclusive).
- Having been continuously treated with RMS Disease Modifying Therapies.
Key Exclusion criteria:
- Pregnant or nursing (lactating) women.
- Patients with any medically unstable condition as determined by the investigator.
- Certain cardiac risk factors defined in the protocol
- History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623243
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | Novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | Novartis.email@novartis.com |

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03623243 |
Other Study ID Numbers: |
CBAF312AUS02 |
First Posted: | August 9, 2018 Key Record Dates |
Last Update Posted: | March 24, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple sclerosis Relapsing multiple sclerosis Advancing multiple sclerosis conversion siponimod |
adult BAF312 disease modifying therapies cognitive assessment open-label |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Siponimod Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |