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NCT00334958 · ClinicalTrials.gov registry record · Phase 3
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
A Phase 3 study of Epilepsy, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
- 20
- Study locations
NCT00334958: Completed Phase 3 study of Epilepsy, sponsored by Eisai.
NCT00334958 is a Phase 3 study of Epilepsy that has completed, run by Eisai. The registered enrollment target is 356 participants, below the 950-participant average among 160 other Epilepsy trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00334958, a Phase 3 study of Epilepsy, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
Primary Outcome
Seizure data was collected via patient diary, which was used to record daily seizure count and type. Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rufinamide
Study Locations (20)
Florida
- Bradenton Research Center - Bradenton
- University of Florida, Dept. of Neurology - Gainesville
- University of Florida, The Neuroscience Institute at Shands - Jacksonville
- Pediatric Neurologists of Palm Beach - Loxahatchee Groves
- Nemours Children's Clinic - Orlando
- Pediatric Neurology - PA - Orlando
- Bay Medical Center - Panama City
- University of Southern Florida, Dept. of Neurology - Tampa
Arizona
- Barrow Neurological Institute - Phoenix
- Mayo Clinic Epilepsy and Neurology - Phoenix
- University of Arizona, Dept. of Neurology - Tucson
California
- Neuro-Pain Medical Center, Inc. - Fresno
- Neurology Center - Oceanside
- California Pacific Epilepsy - San Francisco
Alabama
- University of South Alabama Medical Center - Mobile
- Neurology Clinic PC - Northport
District of Columbia
- Georgetown University Hospital, Dept. of Neurology - Washington D.C.
- Children's National Medical Center - Washington D.C.
Arkansas
- Clinical Trials, Inc - Little Rock
Georgia
- Child Neurology Associates, PC - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2006-02-13 |
| Est. Completion | 2009-05-20 |
| Phase | Phase 3 |
What the finished NCT00334958 record still lists
NCT00334958 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, below the 950-participant average among 160 other Epilepsy trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00334958 names 20 study sites across 7 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT00334958 about?
NCT00334958 is a clinical study titled "Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures". To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
What is the current status of trial NCT00334958?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2006-02-13. Estimated completion is 2009-05-20.
What conditions does trial NCT00334958 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT00334958?
The interventions under investigation include: Placebo (DRUG), Rufinamide (DRUG).
Who is sponsoring clinical trial NCT00334958?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00334958 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epilepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00334958's enrollment target sits among peer trials
356 18th of 160 higher than 143 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy 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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