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

NCT01665144

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Secondary Progressive Multiple Sclerosis

Interventions: BAF312, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (290)
  • Phoenix, Arizona, United States
  • Berkeley, California, United States
  • Los Angeles, California, United States
  • Oceanside, California, United States
  • Sacramento, California, United States
  • Aurora, Colorado, United States
  • Basalt, Colorado, United States
  • Boulder, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Englewood, Colorado, United States
  • Fairfield, Connecticut, United States
  • Delray Beach, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Ormond Beach, Florida, United States
  • Port Charlotte, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Vero Beach, Florida, United States
  • Chicago, Illinois, United States
  • Evanston, Illinois, United States
  • Flossmoor, Illinois, United States
  • Lenexa, Kansas, United States
  • Baltimore, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • Plymouth, Minnesota, United States
  • St Louis, Missouri, United States
  • + 260 more on CT.gov