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

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Trial ID: NCT01665144

Age - 18 Years-60 Years Condition - Multiple Sclerosis Gender - All Accepting Healthy Volunteers - No

Purpose

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).

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.

Eligibility


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.

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Intervention(s):

drug: BAF312

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angela Campbell
650-721-6188

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