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

Recruitment Period:
March 2014-ongoing

Location of Study/Trial:
Lahey Outpatient Center, Lexington
16 Hayden Ave,
Lexington, MA 02421

And

Lahey Hospital and Medical Center
41 Mall Road
Burlington, MA 01805

Recruiting:

Inclusion-

• Diagnosed with Secondary Progressive Multiple Sclerosis (SPMS)
• 18-60 years of age
• EDSS including and between 3.0 and 6.5
• Confirmed disease progression in the last two years
• No relapse in past 3 months

Exclusion-

• Non-SPMS patients
• Clinical relapse in last 3 months
• HIV positive, Positive for either Hepatitis A, B, or C
• Diagnosed with macular edema
• Prior treatment with BAF312
• Pregnant or currently breast-feeding

Principal Investigator:
Ann Camac, MD, Lahey MS Center

Sponsor:
Novartis

Purpose/Methodology:
Since there are no approved treatments for SPMS, a need exists to study potential treatments for those who have SPMS. This study is designed to assess if BAF312 is an effective therapy for SPMS patients. Patients will receive either BAF312 or a placebo pill; patients have a 66% chance of receiving BAF312 and 33% chance of receiving placebo. Neither you nor your study doctor will know to which treatment option you were assigned. The study will last for at least 2 years. After the screening and initial dosing period, patients are asked to come in once every 3 months. Study assessments include neurological exams, skin and eye exams, brain MRIs, as well as other tests and assessments.