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NCT00340834 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,292
- Enrollment target
NCT00340834: Completed Phase 3 study, sponsored by Novartis.
NCT00340834 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 1,292 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340834, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,292 participants
- Enrollment target
Study Summary
This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
Primary Outcome
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, numbe
Interventions
- DRUG Fingolimod 1.25 mg
- DRUG Fingolimod 0.5 mg
- DRUG Interferon β-1a 30 µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,292 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00340834 record still lists
NCT00340834 is an interventional study that assigns participants to a tested intervention. Its 1,292 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 (67% higher).
The record links to 0 conditions, and to 3 interventions - of which Fingolimod 1.25 mg is the first listed.
NCT00340834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00340834 about?
NCT00340834 is a clinical study titled "Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase". This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
What is the current status of trial NCT00340834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,292 participants. The study started on 2006-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00340834?
The interventions under investigation include: Fingolimod 1.25 mg (DRUG), Fingolimod 0.5 mg (DRUG), Interferon β-1a 30 µg (DRUG).
Who is sponsoring clinical trial NCT00340834?
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 NCT00340834's enrollment target sits among peer trials
1,292 196th of 2000 higher than 1,805 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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