CLINICAL TRIALS PROFILE FOR SIPONIMOD

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.
NCT03623243 ↗	Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.	Recruiting	Novartis Pharmaceuticals	Phase 3	2019-02-14	To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
NCT04792567 ↗	Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)	Recruiting	Novartis Pharmaceuticals	Phase 4	2021-04-19	The purpose of this study is to understand whether participants can mount an immune response to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or during a treatment break.

Clinical Trial Conditions for siponimod

Condition Name

Condition Name for siponimod
Intervention	Trials
Relapsing Remitting Multiple Sclerosis	2
Secondary Progressive Multiple Sclerosis	2
Multiple Sclerosis	1
Multiple Sclerosis (MS)	1

Condition MeSH

Condition MeSH for siponimod
Intervention	Trials
Multiple Sclerosis	7
Sclerosis	7
Neoplasm Metastasis	3
Multiple Sclerosis, Chronic Progressive	3

Clinical Trial Locations for siponimod

Trials by Country

Trials by Country for siponimod
Location	Trials
United States	78
Japan	12
Spain	12
Canada	8
Italy	8

Trials by US State

Trials by US State for siponimod
Location	Trials
Florida	5
California	4
Ohio	4
Oregon	4
Washington	3

Clinical Trial Progress for siponimod

Clinical Trial Phase

Clinical Trial Phase for siponimod
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for siponimod
Clinical Trial Phase	Trials
Recruiting	4
Completed	2
Active, not recruiting	2

Clinical Trial Sponsors for siponimod

Sponsor Name

Sponsor Name for siponimod
Sponsor	Trials
Novartis Pharmaceuticals	7
Providence Health & Services	1
Robert Zivadinov, MD, PhD	1

Sponsor Type

Sponsor Type for siponimod
Sponsor	Trials
Industry	7
Other	2