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

• Status: Active, not recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Siponimod

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.