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Efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis

Type of intervention
Drug

Form of MS
Secondary Progressive MS

Brief summary
People with progressive multiple sclerosis (MS) have limited treatment options compared to non-progressive forms of MS. This clinical trial will evaluate if the investigational therapy, BAF312 (Siponimod) is safe and has beneficial effects in people who have Secondary Progressive Multiple Sclerosis (SPMS).

The target is to recruit 1530 volunteers with symptoms consistent with secondary-progressive MS from over 30 countries worldwide. About one-third of these participants (determined randomly) will receive placebo and two-thirds will receive BAF312, however neither the participant nor treating doctor will know which treatment is being received.

During the study, participants will be required to take a daily oral pill. They will also attend study visits every 3 months to be examined by an MS specialist and also take part in a number of study specific evaluations.

Participation in the study will last from a minimum of 23 months up to approximately 42 months depending on when you enter. This may need to be extended to up to 60 months.

Inclusion Criteria:
• Between 18 and 60 years old
• 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

Anticipated start date
Trial already commenced at all trial sites – first patient visit was April 2013

Recruitment status
Recruiting is currently ongoing until October 2014

Recruitment contacts
BMRI, Sydney, NSW – Marinda Taha
marinda.taha@sydney.edu.au
02 9351 0704

Liverpool Hospital, Sydney, NSW – Sue Baker
sue.baker@sswahs.nsw.gov.au
02 9616 4687

Southern Neurology, Kogarah, NSW – Melissa Murphy
mmurphy@southern-neurology.com.au
1300 114 439

Royal Melbourne Hospital, Melbourne, VIC – Lisa Taylor
03 9342 7061

The Austin Hospital, Heidelberg, VIC – Elise Heriot
Elise.heriot@austin.org.au
03 9496 3705

Further details
http://clinicaltrials.gov/show/NCT01665144

For more information on Siponimod see also a news article on the phase II trial results for Siponimod in relapsing remitting MS

Region
New South Wales and Victoria

Trial results
In a previous phase II study 188 people with relapsing remitting MS, siponimod taken for 3 to 6 months reduced the number of brain lesions seen in MRI by up to 80% and reduced relapse rates compared to placebo (0.58 on placebo to 0.2 on 2 mg siponimod).

Last updated
April 2014