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NCT01185821 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
185
Enrollment target

NCT01185821 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 185 participants.

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The verdict

NCT01185821, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
185 participants
Enrollment target

Study 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

Interventions

  • DRUG BAF312

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 2010-08-30
Est. Completion 2016-10-10
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01185821

The ClinicalTrials.gov registry entry for NCT01185821 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which BAF312 is the first listed.

NCT01185821 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01185821 about?

NCT01185821 is a clinical study titled "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 treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term sa...

What is the current status of trial NCT01185821?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2010-08-30. Estimated completion is 2016-10-10.

What interventions are being tested in trial NCT01185821?

The interventions under investigation include: BAF312 (DRUG).

Who is sponsoring clinical trial NCT01185821?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.