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Sponsored by: |
Eisai Medical Research Inc. |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00448539 |
This study is an open-label extension of Study E2080-A001-301. All patients will initiate the study at the total daily doses they were receiving at the end of the transition phase in E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator, to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure frequency will be monitored throughout the study.
Condition | Intervention | Phase |
Refractory Partial Onset Seizures |
Drug: Rufinamide |
Phase III |
Genetics Home Reference related topics: | pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy |
MedlinePlus related topics: | Seizures |
Drug Information available for: | Rufinamide |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures |
Estimated Enrollment: | 408 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Rufinamide
400 mg tablet administered in two equally divided daily doses.
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Ages Eligible for Study: | 12 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contact: Eisai Medical Services | 1-888-422-4743 |
Show 26 Study Locations |
Eisai Medical Research Inc. |
Study Director: | Allison Mann, M.D. | Eisai Medical Research Inc. |
Responsible Party: | Eisai Medical Research Inc. ( Allison Mann, MD ) |
Study ID Numbers: | E2080-A001-302 |
First Received: | March 15, 2007 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00448539 |
Health Authority: | United States: Food and Drug Administration |
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