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NCT00355134 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,083
- Enrollment target
NCT00355134: Completed Phase 3 study, sponsored by Novartis.
NCT00355134 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 1,083 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00355134, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,083 participants
- Enrollment target
Study Summary
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
Primary Outcome
ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating ev
Interventions
- DRUG Placebo
- DRUG Fingolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,083 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00355134 record still lists
NCT00355134 is an interventional study that assigns participants to a tested intervention. Its 1,083 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00355134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00355134 about?
NCT00355134 is a clinical study titled "Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis". This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
What is the current status of trial NCT00355134?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,083 participants. The study started on 2006-06. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00355134?
The interventions under investigation include: Placebo (DRUG), Fingolimod (DRUG).
Who is sponsoring clinical trial NCT00355134?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00355134's enrollment target sits among peer trials
1,083 269th of 2000 higher than 1,732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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