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

Completed · Phase 3 · Has a placebo group

Conditions studied: Secondary Progressive Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT01665144

Run by

Novartis Pharmaceuticals

People needed

1651

Starts

2012-12-20

Expected to finish

2023-03-31

Last updated by the study team

2024-06-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Berkeley, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Basalt, Colorado, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Englewood, Colorado, United States
• Novartis Investigative Site — Fairfield, Connecticut, United States
• Novartis Investigative Site — Delray Beach, Florida, United States
• Novartis Investigative Site — Hollywood, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Maitland, Florida, United States
• Novartis Investigative Site — Ormond Beach, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Vero Beach, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Evanston, Illinois, United States
• Novartis Investigative Site — Flossmoor, Illinois, United States
• Novartis Investigative Site — Lenexa, Kansas, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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