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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00448539

Purpose

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Rufinamide

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Long-term efficacy of rufinamide (i.e., effects on seizure frequency) will be assessed by Patient Seizure Diaries completed by the patient or caregiver. [ Time Frame: Visit 2 through Visit 6. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety assessments will include adverse events (nature, frequency, and intensity), vital signs, brief physical and neurological examination, clinical laboratory evaluations, and ECG. [ Time Frame: Safety variables will be monitored at 8-week intervals during the first 32 weeks, then at 16-week intervals thereafter. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	408
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2011
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.

Eligibility

Ages Eligible for Study:	12 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Completion of Study E2080-A001-301 and full compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
Patient willing to participate and written consent signed by patient or legal guardian provided prior to entering this study or undergoing any study procedures. In addition, if the patient is unable to provide written informed consent and it is provided by a legal guardian, assent of the patient (if the patient is able) must also be obtained.
Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); female patients of childbearing potential who are using at least two approved methods of contraception (such as an intrauterine device [IUD], implant, oral contraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oral contraceptive alone will not be permitted. Female patients of childbearing potential must agree to continue to use two approved methods of contraception through the follow-up visit or for 30 days after their final dose of study medication, whichever is longer.

EXCLUSION CRITERIA:

Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic (e.g., ALT > 3x ULN), hematologic, renal, or psychiatric disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
History of alcohol abuse in the past 2 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448539

Show 27 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Francesco Bibbiani, M.D.

Eisai Inc.

More Information

No publications provided

Responsible Party:	Eisai Medical Research Inc. ( Francesco Bibbiani, MD )
Study ID Numbers:	E2080-A001-302
Study First Received:	March 15, 2007
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00448539 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Signs and Symptoms
Epilepsy
Nervous System Diseases
Seizures

Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010