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NCT00731692 · ClinicalTrials.gov registry record · Phase 3
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 970
- Enrollment target
NCT00731692: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00731692 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 970 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00731692, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 970 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population
Primary Outcome
3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower e
Interventions
- DRUG Placebo
- DRUG FTY720
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 970 participants |
| Start Date | 2008-07-28 |
| Est. Completion | 2015-06-22 |
| Phase | Phase 3 |
Why NCT00731692 stopped before completion
NCT00731692 is an interventional study that assigns participants to a tested intervention. The registered 970 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00731692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00731692 about?
NCT00731692 is a clinical study titled "This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.". The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core ...
What is the current status of trial NCT00731692?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 970 participants. The study started on 2008-07-28. Estimated completion is 2015-06-22.
What interventions are being tested in trial NCT00731692?
The interventions under investigation include: Placebo (DRUG), FTY720 (DRUG).
Who is sponsoring clinical trial NCT00731692?
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 NCT00731692's enrollment target sits among peer trials
970 329th of 2000 higher than 1,671 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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