Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Completed
Novartis Pharmaceuticals
Phase 2
2010-08-30
This study consisted of a two year dose blinded phase during which patients received one of
five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched
to open label treatment with siponimod 2mg for approximately a further 3 years. It will
provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient
population
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Active, not recruiting
Novartis Pharmaceuticals
Phase 3
2012-12-20
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).
This study investigated the dose response relationship for the efficacy and safety of BAF312
compared to placebo in active DM patients over a treatment period of 6+6 months and to
determine the minimum dose required for a maximal clinical effect. The study was composed of
2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2,
10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of
2 mg daily .
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
