Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Eisai.
NCT00448539 is a Phase 3 study that was terminated before completion, run by Eisai. The registered enrollment target is 286 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Interventions
- DRUG Rufinamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2007-03-15 |
| Est. Completion | 2010-05-14 |
| Phase | Phase 3 |
Why NCT00448539 stopped before completion
NCT00448539 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Rufinamide is the first listed.
NCT00448539 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00448539's enrollment target sits among peer trials
286 1182nd of 2000 higher than 816 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04781140 · 286 participants · Phase 4
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
- NCT04936529 · 286 participants · Phase 2
A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
- NCT05183646 · 286 participants · Phase 3
A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB
- NCT05506878 · 286 participants · NA
Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI