CLINICAL TRIALS PROFILE FOR SIPONIMOD
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All Clinical Trials for Siponimod
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01185821 ↗ | 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 |
| NCT01665144 ↗ | 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). |
| NCT02029274 ↗ | Safety and Efficacy of BAF312 in Dermatomyositis | Terminated | Novartis Pharmaceuticals | Phase 2 | 2013-08-25 | 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 . |
| NCT03338998 ↗ | Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH). | Completed | Novartis Pharmaceuticals | Phase 2 | 2017-12-24 | This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH) |
| NCT03498131 ↗ | Melatonin in Patients With Multiple Sclerosis (MS). | Active, not recruiting | Providence Health & Services | Early Phase 1 | 2018-05-09 | To date, there are no published data on the role of melatonin supplementation or the appropriate dose for patients with multiple sclerosis. Because of the potential benefits of melatonin, this pilot study will be an exploratory investigation to evaluate the effect of supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this study will support the rationale and be a prelude to a larger trial which can focus on clinical efficacy of melatonin therapy outcomes. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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