Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Relapsing Remitting Multiple Sclerosis
In brief
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
Key facts
- Study ID
- NCT01185821
- Run by
- Novartis Pharmaceuticals
- People needed
- 185
- Starts
- 2010-08-30
- Expected to finish
- 2016-10-10
- Last updated by the study team
- 2018-03-27
Who can join
Age: 18 and older, up to 56. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
- Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
- Active infections
Where it is running
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Pompano Beach, Florida, United States
- Novartis Investigative Site — Tallahassee, Florida, United States
- Novartis Investigative Site — Chicago, Illinois, United States
- Novartis Investigative Site — Grand Rapids, Michigan, United States
- Novartis Investigative Site — Akron, Ohio, United States
- Novartis Investigative Site — Greenville, South Carolina, United States
- Novartis Investigative Site — Seattle, Washington, United States
- Novartis Investigative Site — Ottawa, Ontario, Canada
- Novartis Investigative Site — Gatineau, Quebec, Canada
- Novartis Investigative Site — Greenfield Park, Quebec, Canada
- Novartis Investigative Site — Helsinki, Finland
- Novartis Investigative Site — Tampere, Finland
- Novartis Investigative Site — Dresden, Germany
- Novartis Investigative Site — Ibbenbueren, Germany
- Novartis Investigative Site — München, Germany
- Novartis Investigative Site — Münster, Germany
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Debrecen, Hungary
- Novartis Investigative Site — Veszprém, Hungary
- Novartis Investigative Site — Montichiari, BS, Italy
- Novartis Investigative Site — Chieti, CH, Italy
- Novartis Investigative Site — Roma, RM, Italy
- Novartis Investigative Site — Roma, RM, Italy
Full record on ClinicalTrials.gov
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