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NCT00448539 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
A Phase 3 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 3
- Development phase
- 286
- Enrollment target
NCT00448539 is a Phase 3 study that was terminated before completion, run by Eisai. The registered enrollment target is 286 participants.
The verdict
NCT00448539, a Phase 3 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 286 participants
- Enrollment target
Study Summary
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
Interventions
- DRUG Rufinamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2007-03-15 |
| Est. Completion | 2010-05-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00448539
The ClinicalTrials.gov registry entry for NCT00448539 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rufinamide is the first listed.
NCT00448539 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00448539 about?
NCT00448539 is a clinical study titled "Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures". This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control ...
What is the current status of trial NCT00448539?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2007-03-15. Estimated completion is 2010-05-14.
What interventions are being tested in trial NCT00448539?
The interventions under investigation include: Rufinamide (DRUG).
Who is sponsoring clinical trial NCT00448539?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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