Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT01665144
• Date of registration: 03/08/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
• Scientific 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.
• Date of first enrolment: December 20, 2012
• Target sample size: 1653
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01665144
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Czechia, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Secondary Progressive Multiple Sclerosis

Intervention(s)

Drug: BAF312

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Overall Response Rate on the MSWS-12. [Time Frame: Baseline, every 6 months up to the maximum of approximately 3 years]

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]

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 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]

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]

Secondary ID(s)

CBAF312A2304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01665144