Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
NCT ID: NCT00334958
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2006-02-13
2009-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets will be administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet will be administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
Placebo
For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily.
Rufinamide
For the 12-day Titration Phase, rufinamide will be administered orally in doses starting with 400 milligram (mg) twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
Rufinamide
For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
Interventions
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Placebo
For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily.
Rufinamide
For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures according with the International League Against Epilepsy Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain performed within the last 10 years and consistent with localization-related epilepsy.
3. Non-controlled partial seizures despite having been treated with at least two different antiepileptic drugs (given concurrently or sequentially) for at least two years.
4. Patient willing to participate and written consent signed by patient or legal guardian prior to entering the study or undergoing any study procedures. If the written consent is provided by a legal guardian because the patient is unable to do so, assent of the patient must also be obtained.
5. Reliability and willingness of patients to make themselves available for the study period, and ability to record seizures and report adverse events themselves or have a caregiver who can record seizures and report adverse events.
6. Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); or of childbearing potential using 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 ("minipill") alone will not be permitted. Female patients of childbearing potential must have a confirmed negative serum pregnancy test at screening and a negative urine pregnancy test prior to randomization, and agree to continue to use two approved methods of contraception through the follow-up visit (Visit 8) or for 30 days after their final dose of study medication, whichever is longer.
7. At least six seizures during the prospective Baseline Phase (56 days) with no 21-day seizure-free periods. Simple partial seizures without motor signs will not be included in determining this criterion.
8. Current treatment with a maximum of three approved antiepileptic drugs, and no evidence of non-compliance with ongoing AED therapy.
9. Stable dose(s) of the same AED(s) for one month prior to screening.
10. If using a vagal nerve stimulator, it must have been implanted for at least six months prior to randomization. Stimulator parameters may not be changed for at least one month prior to screening or thereafter during the study. Magnet use will be allowed, but must be documented throughout the study. A vagal nerve stimulator will not be counted as an AED for the purpose of inclusion into the trial.
Exclusion Criteria
2. Presence of non-motor simple partial seizures only.
3. Presence of generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
4. History of status epilepticus in the past year or seizure clusters where individual seizures cannot be counted.
5. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic or renal disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
6. Clinically significant ECG abnormality.
7. Patients with a diagnosis of major active psychiatric disease will be excluded from the study. However, those patients who are only taking a stable dose of either a selective serotonin reuptake inhibitor (SSRI) antidepressant drug or a serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant drug for a diagnosed depressive disorder can be included as long as they have been on the SSRI or SNRI for a period of two months or longer before randomization. Other antidepressant medications will not be allowed.
8. Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
9. Occurrence of psychogenic seizures in the previous year.
10. History of drug abuse and/or positive finding on urinary drug screening, other than prescribed medication
11. History of alcohol abuse in the past two years.
12. History of suicide attempt within the previous 10 years.
13. Multiple drug allergies (dermatological, hematological or organ toxicity) or more than one severe drug reaction(s).
14. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
15. Frequent need of rescue benzodiazepines (more than once a month).
16. Patients with a known hypersensitivity to rufinamide, triazole derivatives, or to any excipients used in the formulation.
17. Concomitant use of vigabatrin. Patients who took vigabatrin in the past must be off vigabatrin for at least five months prior to Visit 1 and must not have evidence of a clinically significant abnormality in a visual perimetry test.
18. 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 judgment.
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
Neurology Clinic PC
Northport, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Mayo Clinic Epilepsy and Neurology
Phoenix, Arizona, United States
University of Arizona, Dept. of Neurology
Tucson, Arizona, United States
Clinical Trials, Inc
Little Rock, Arkansas, United States
Neuro-Pain Medical Center, Inc.
Fresno, California, United States
Neurology Center
Oceanside, California, United States
California Pacific Epilepsy
San Francisco, California, United States
Georgetown University Hospital, Dept. of Neurology
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Bradenton Research Center
Bradenton, Florida, United States
University of Florida, Dept. of Neurology
Gainesville, 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
Nemours Children's Clinic
Orlando, Florida, United States
Pediatric Neurology - PA
Orlando, Florida, United States
Bay Medical Center
Panama City, Florida, United States
University of Southern Florida, Dept. of Neurology
Tampa, Florida, United States
Child Neurology Associates, PC
Atlanta, Georgia, United States
Medical College of Georgia, Dept. of Neurology
Augusta, Georgia, United States
Medical Associates of North Georgia
Canton, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Children's Memorial Hospital, Northwest University
Chicago, Illinois, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, United States
Southern Illinois University Neurology and Pharmacology
Springfield, Illinois, United States
Mcfarland Clinic
Ames, Iowa, United States
Via Christi Comprehensive Epilepsy Center
Wichita, Kansas, United States
University of Kentucky, Dept. of Neurology
Lexington, Kentucky, United States
John Hopkins Hospital, Dept. of Neurology
Baltimore, Maryland, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Boston University Medical Center, Dept. of Neurology
Boston, Massachusetts, United States
University of Massachusetts, Neurology Associates
Hopedale, Massachusetts, United States
University of Minnesota, Dept. of Neurology
Minneapolis, Minnesota, United States
Minnesota Epilepsy Group, PC
Saint Paul, Minnesota, United States
Ronald Schwartz, M.D.
Hattiesburg, Mississippi, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
The Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, United States
Saint John's Medical Research
Springfield, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Dartmouth Medical School Neuroscience Center
Lebanon, New Hampshire, United States
Five Towns Neuroscience Research
Lawrence, 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
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill, Dept. of Neurology
Chapel Hill, North Carolina, United States
Duke Health Center at Morreene Road
Durham, North Carolina, United States
Cleveland Clinic Foundation, Dept. of Neurology
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Medical University of Ohio at Toledo, Dept. of Neurology
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Blair Medical Associates, Inc.
Altoona, Pennsylvania, United States
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania, Dept. of Neurology
Philadelphia, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh - Dept of Pediatrics
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Mid-South Physicians Group, PLLC
Germantown, Tennessee, United States
University of Tennessee Health Sciences Center, Dept. of Neurology
Memphis, Tennessee, United States
UT Medical Group
Memphis, Tennessee, United States
Access Clinical Trials, Inc
Nashville, Tennessee, United States
Neurological Clinic of Texas, PA
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
El Paso, Texas, United States
University of Texas - Dept of Neurology
Houston, Texas, United States
Baylor Medical Center of Irving
Irving, Texas, United States
Epilepsy and Neurodevelopment, Inc.
West Jordan, Utah, United States
University of Vermont, College of Medicine, Clinical Neurophysiology Lab
Burlington, Vermont, United States
Fletcher Allen Healthcare
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington, Harborview Medical Center, Regional Epilepsy Center
Seattle, Washington, United States
University of Wisconsin, Dept. of Neurology
Madison, Wisconsin, United States
Countries
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References
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Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.
Other Identifiers
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2016-004944-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2080-A001-301
Identifier Type: -
Identifier Source: org_study_id
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