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Terminated Phase 3 Interventional Results available

Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

ClinicalTrials.gov ID: NCT00448539

Public ClinicalTrials.gov record NCT00448539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00448539
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eisai Inc.
Industry
Enrollment
286 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 15, 2007 (Actual)
Primary completion
May 14, 2010 (Actual)
Completion
May 14, 2010 (Actual)
Last update posted
Nov 22, 2019

2007 – 2010

United States locations

U.S. sites
27
U.S. states
17
U.S. cities
25
Facility City State ZIP Site status
University of South Alabama Medical Center Mobile Alabama 36693 —
Clinical Trials, Inc. Little Rock Arkansas 72205 —
Bradenton Research Center Bradenton Florida 34205 —
University of Florida, The Neuroscience Institute at Shands Jacksonville Florida 32209 —
Pediatric Neurologists of Palm Beach Loxahatchee Groves Florida 33470 —
Pediatric Neurosciences, PA Orlando Florida 32835 —
Bay Medical Center Panama City Florida 32405 —
Child Neurology Associates, PC Atlanta Georgia 30342 —
Southern Illinois University Neurology and Pharmacology Springfield Illinois 62794-9643 —
McFarland Clinic PC Ames Iowa 50010-3014 —
John Hopkins Hospital, Dept. of Neurology Baltimore Maryland 21287 —
Hattiesburg Clinic Hattiesburg Mississippi 39401 —
Comprehensive Epilepsy Care Center for Children and Adults Chesterfield Missouri 63017 —
Dartmouth Medical School Neuroscience Center Lebanon New Hampshire 03756-0001 —
Five Towns Neuroscience Research Cedarhurst New York 11516 —
New York University Medical Centre, Comprehensive Epilepsy Center New York New York 10016 —
Weill Cornell Medical Center, Comprehensive Epilepsy Center New York New York 10021 —
Asheville Neurology Specialists Asheville North Carolina 28806 —
Ohio State University Columbus Ohio 43210 —
Medical University of Ohio at Toledo - Dept. of Neurology Toledo Ohio — —
Hospital of The University of Pennsylvania Philadelphia Pennsylvania 19104-4204 —
University of Pennsylvania Medical Center-Department of Neurology Philadelphia Pennsylvania 19104-4283 —
University of Tennessee Health Sciences Center, Dept. of Neurology Memphis Tennessee 38105 —
Access Clinical Trials, Inc Nashville Tennessee 37203 —
Neurological Clinic of Texas, P.A. Dallas Texas 75230 —
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry El Paso Texas 79905 —
Fletcher Allen Healthcare Burlington Vermont 05401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00448539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 22, 2019 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00448539 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →