Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
NCT ID: NCT00448539
Last Updated: 2019-11-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
286 participants
INTERVENTIONAL
2007-03-15
2010-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rufinamide (Rufinamide During Core Study)
Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Rufinamide (Placebo During Core Study)
Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Interventions
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Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
3. 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.
1. Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
2. Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
3. 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.
4. Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
5. History of alcohol abuse in the past 2 years.
6. History of suicide attempt within the previous 10 years.
7. Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
8. Concomitant use of felbamate or vigabatrin.
9. Pregnancy.
10. Clinically significant ECG abnormality.
11. All patients with a diagnosis of Congenital Short QT Syndrome. Patients with a family history of Congenital Short QT Syndrome may be excluded on the basis of the Investigator's clinical judgement.
12. Presence of major active psychiatric disorder. Patients will be allowed who are taking a stable dose of selective serotonin reuptake inhibitor (SSRI) or mixed serotonin and norepinephrine uptake inhibitor antidepressant.
12 Years
80 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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University of South Alabama Medical Center
Mobile, Alabama, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Bradenton Research Center
Bradenton, Florida, United States
University of Florida, The Neuroscience Institute at Shands
Jacksonville, Florida, United States
Pediatric Neurologists of Palm Beach
Loxahatchee Groves, Florida, United States
Pediatric Neurosciences, PA
Orlando, Florida, United States
Bay Medical Center
Panama City, Florida, United States
Child Neurology Associates, PC
Atlanta, Georgia, United States
Southern Illinois University Neurology and Pharmacology
Springfield, Illinois, United States
McFarland Clinic PC
Ames, Iowa, United States
John Hopkins Hospital, Dept. of Neurology
Baltimore, Maryland, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, United States
Dartmouth Medical School Neuroscience Center
Lebanon, New Hampshire, United States
Five Towns Neuroscience Research
Cedarhurst, New York, United States
New York University Medical Centre, Comprehensive Epilepsy Center
New York, New York, United States
Weill Cornell Medical Center, Comprehensive Epilepsy Center
New York, New York, United States
Asheville Neurology Specialists
Asheville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Medical University of Ohio at Toledo - Dept. of Neurology
Toledo, Ohio, United States
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pennsylvania Medical Center-Department of Neurology
Philadelphia, Pennsylvania, United States
University of Tennessee Health Sciences Center, Dept. of Neurology
Memphis, Tennessee, United States
Access Clinical Trials, Inc
Nashville, Tennessee, United States
Neurological Clinic of Texas, P.A.
Dallas, Texas, United States
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
El Paso, Texas, United States
Fletcher Allen Healthcare
Burlington, Vermont, United States
Countries
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Other Identifiers
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2016-004950-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2080-A001-302
Identifier Type: -
Identifier Source: org_study_id
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