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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 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 970 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00731692
The ClinicalTrials.gov registry entry for NCT00731692 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 970 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 2 interventions - of which Placebo is the first listed.
NCT00731692 reports 0 study locations.
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.
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