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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 : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

Condition or disease Intervention/treatment Phase
Secondary Progressive Multiple Sclerosis Drug: BAF312 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.
 Drug: Placebo
Film-coated tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior history of relapsing remitting MS
  • SPMS defined as progressive increase of disability over at least 6 months
  • EDSS score of 3.0 to 6.5
  • No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

  • Women of child bearing potential must use reliable forms of contraception.
  • Diagnosis of Macular edema during screening period
  • Any medically unstable condition determined by investigator.
  • Unable to undergo MRI scans
  • Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.
Contacts and Locations
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Information from the National Library of Medicine

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


  Show 314 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01665144     History of Changes
Other Study ID Numbers: CBAF312A2304
First Posted: August 15, 2012    Key Record Dates
Results First Posted: October 31, 2018
Last Update Posted: September 9, 2019
Last Verified: September 2019
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

Locations: central Contact Info Novartis.email@novartis.com
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Secondary Progressive Multiple Sclerosis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms