CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 185 enrolled
Drug / intervention
BAF312drug
Likely dose
BAF312 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01185821
NCT01185821Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Aug 20, 2010·Updated Mar 27, 2018

In Brief

A Phase 2 clinical trial evaluating BAF312 for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 185 participants across 46 sites in 12 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
CountriesCanada, Finland, Germany, Hungary, Italy, Norway, Poland, Russia, Spain, Switzerland, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 20, 2010
Enrollment StartAug 30, 2010
Primary CompletionOct 10, 2016
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 15.9 years ago

Interventions

BAF312drug

BAF312 was supplied in film-coated tablets in strengths of 5, 4 ,2, 1, .5 and .25 mg. The actual doses taken were 10, 2, 1.25, .5 and .25 mg taken orally once a day.