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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: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01185821 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 185 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.
Interventions
- DRUG BAF312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2010-08-30 |
| Est. Completion | 2016-10-10 |
| Phase | Phase 2 |
What the finished NCT01185821 record still lists
NCT01185821 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 1 intervention - of which BAF312 is the first listed.
NCT01185821 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01185821's enrollment target sits among peer trials
185 357th of 2000 higher than 1,641 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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