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COMPLETEDPhase 2NCT01185821

Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

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 tr...

Lead sponsor: Novartis Pharmaceuticals•8 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novartis Pharmaceuticals

This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.

Age

18 - 56 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients completed the core study BAF312A2201
•Written informed consent provided before any assessment of the extension study
•Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

Exclusion Criteria

•Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
•Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
•Active infections

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 27, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment185

Start dateAug 2010

Last updatedMar 27, 2018

Condition

Relapsing Remitting Multiple Sclerosis

Locations shown

Novartis Investigative Site

Miami, Florida

Novartis Investigative Site

Pompano Beach, Florida

Novartis Investigative Site

Tallahassee, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2018Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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