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 : March 31, 2020
|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 :||March 1, 2024|
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 ]The reduction of the increase in the 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 ]BAF312 vs placebo 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.
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): NCT01665144
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|