To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
185
Siponimod 2mg tablets taken once daily
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as the AEs started after the first dose of siponimod to 30 days after the date of the last actual administration, or events present prior to start of treatment but which increased in severity. TEAEs suspected to be related to study drug are reported.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Number of Participants With at Least One Adverse Event (AE)
AE is any untoward sign or symptom that occurs during the study treatment plus 30 days post treatment.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9)
TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.
Time frame: Baseline up to Day 168
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Cullman, Alabama, United States
Alabama Neurology Associates
Homewood, Alabama, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Fresno, California, United States
Novartis Investigative Site
Fullerton, California, United States
Novartis Investigative Site
Irvine, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Fort Collins, Colorado, United States
...and 45 more locations
Change in Heart Rate From Baseline to 6 Hours After First Treatment
Heart rate was evaluated from the time of initial dose intake until 6 hours post dose intake via heart monitor.
Time frame: From the first dose up to 6 hours
Number of Participants With at Least One Hospitalization During the Treatment
Time frame: From first dose of study drug up to last dose of study drug (up to 6 months)
Patient Retention Reported as Number of Participants Who Completed the Study
Patient retention was assessed over the study period.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)