Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
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|ClinicalTrials.gov Identifier: NCT01665144|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2012
Results First Posted : October 31, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Secondary Progressive Multiple Sclerosis||Drug: BAF312 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1652 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.|
|Actual Study Start Date :||December 20, 2012|
|Actual Primary Completion Date :||April 29, 2016|
|Estimated Study Completion Date :||September 22, 2023|
Experimental: Siponimod (BAF312)
Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312.
0.25, 0.5, 1, and 2 mg film-coated tablets
Placebo Comparator: Placebo
Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.
- Percentage of Participants With 3-month Confirmed Disibility Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline, every 3 month up to the maximum of approximately 3 years ]The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.
- Efficacy of BAF312 Relative to Placebo in Confirmed Worsening of 25 Foot Walk Test [ Time Frame: Baseline , every 3 months up to the maximum of approximately 3 years ]Delay in time to 3 month confirmed worsening of at least 20% from baseline in the timed 25 foot walk test.
- Efficacy of BAF312 Relative to Placebo in Reducing the Increase in T2 Lesion Volume [ Time Frame: Baseline, every year up to the maximum of approximately 3 years ]Efficacy is shown by the reduction of the increase in T1 lesion volume.
- The Delay in Time to Confirmed Disability Progression as Measured by EDSS. [ Time Frame: Baseline, every 6 months up to the maximum of approximately 3 years ]Confirmed disability is defined as increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.
- Efficacy of BAF Relative to Placebo in Annualized Relapses Rate and Time to the First Relapse [ Time Frame: Baseline every 3 months up to the maximum of approximately 3 years ]Efficacy of BAF312 relative to placebo was measured by the effect on confirmed relapses rate, the time to the first relapse, and proportion of patient free from relapses.
- Overall Response Rate on the MSWS-12. [ Time Frame: Baseline, every 6 months up to the maximum of approximately 3 years ]The overall response of the effect of BAF312 compared to placebo patients on the patient reported outcome form MSWS-12.
- Effect on Inflammatory Disease Activity and Burden of Disease as Measured by MRI [ Time Frame: Baseline, every 12 month up to the maximum of approximately 3 years ]Effect of BAF312 relative to placebo on disease activity and burden of disease as measured by Gd-T1 lesion, new/enlarged T2 lesion, and brain atrophy on brain MRI scans.
- Effect on 3-month Confirmed Disability Progression as Defined by EDSS in Predefined Sub-groups [ Time Frame: Baseline, every 3 months up to the maximum of approximately 3 years ]effect on confirmed disability progression in pre-defined subgroups, including patients with or without superimposed relapses, rapidly evolving patients with 1.5 point or greater change in EDSS score in 2 years prior to enrollment into the study. Patients with score of 4 or more in MSSS and those who don't meet this criteria.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665144
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|