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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01185821

Public ClinicalTrials.gov record NCT01185821. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01185821
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
185 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 56 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 30, 2010 (Actual)
Primary completion
Oct 10, 2016 (Actual)
Completion
Oct 10, 2016 (Actual)
Last update posted
Mar 27, 2018

2010 – 2016

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
8
Facility City State ZIP Site status
Novartis Investigative Site Miami Florida 33136 —
Novartis Investigative Site Pompano Beach Florida 33060 —
Novartis Investigative Site Tallahassee Florida 32308 —
Novartis Investigative Site Chicago Illinois 60637 —
Novartis Investigative Site Grand Rapids Michigan 49525 —
Novartis Investigative Site Akron Ohio 44320 —
Novartis Investigative Site Greenville South Carolina 29607 —
Novartis Investigative Site Seattle Washington 98122 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01185821, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 27, 2018 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01185821 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →