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Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Placebo (Drug); Rufinamide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Francesco Bibbiani, M.D., Study Director, Affiliation: Eisai Inc.

Summary

The primary objective of this study is to evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures currently inadequately treated with a maximum of three stable antiepileptic medications. Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between rufinamide plasma concentration and efficacy.

Clinical Details

Official title: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase

Secondary outcome:

Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase

Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase

Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase

Eligibility

Minimum age: 12 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

INCLUSION CRITERIA 1. Male and female patients between 12 and 80 years of age, inclusive. 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: 1. Participation in a study involving administration of an investigational compound within one month of Visit 1 (Screening), or within five half-lives of the previous investigational compound, whichever is longer; or any prior exposure to rufinamide. 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.

Locations and Contacts

University of South Alabama Medical Center, Mobile, Alabama 36693, United States

Neurology Clinic PC, Northport, Alabama 35476, United States

Barrow Neurological Institute, Phoenix, Arizona 85013, United States

Mayo Clinic Epilepsy and Neurology, Phoenix, Arizona 85054, United States

University of Arizona, Dept. of Neurology, Tucson, Arizona 85724-5023, United States

Clinical Trials, Inc, Little Rock, Arkansas 72205, United States

Neuro-Pain Medical Center, Inc., Fresno, California 93710, United States

Neurology Center, Oceanside, California 92056, United States

California Pacific Epilepsy, San Francisco, California 94115, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

Georgetown University Hospital, Dept. of Neurology, Washington, District of Columbia 20007, United States

Bradenton Research Center, Bradenton, Florida 34205, United States

University of Florida, Dept. of Neurology, Gainesville, Florida 32611, United States

University of Florida, The Neuroscience Institute at Shands, Jacksonville, Florida 32209, United States

Pediatric Neurologists of Palm Beach, Loxahatchee, Florida 33470, United States

Nemours Children's Clinic, Orlando, Florida 32835, United States

Pediatric Neurology - PA, Orlando, Florida, United States

Bay Medical Center, Panama City, Florida 32405, United States

University of Southern Florida, Dept. of Neurology, Tampa, Florida 33606, United States

Child Neurology Associates, PC, Atlanta, Georgia 30342, United States

Medical College of Georgia, Dept. of Neurology, Augusta, Georgia 30912, United States

Medical Associates of North Georgia, Canton, Georgia 30114, United States

The Queen's Medical Center, Honolulu, Hawaii 96813, United States

Children's Memorial Hospital, Northwest University, Chicago, Illinois 60614-3394, United States

Advocate Hope Children's Hospital, Oak Lawn, Illinois 60453, United States

Advocate Lutheran General Children's Hospital, Park Ridge, Illinois 60068, United States

Southern Illinois University Neurology and Pharmacology, Springfield, Illinois 62794-9643, United States

Mcfarland Clinic, Ames, Iowa 50010, United States

Via Christi Comprehensive Epilepsy Center, Wichita, Kansas 67214, United States

University of Kentucky, Dept. of Neurology, Lexington, Kentucky 40536-0284, United States

John Hopkins Hospital, Dept. of Neurology, Baltimore, Maryland 21287, United States

Boston University Medical Center, Dept. of Neurology, Boston, Massachusetts 02118, United States

Children's Hospital Boston, Boston, Massachusetts 02115, United States

University of Massachusetts, Neurology Associates, Hopedale, Massachusetts 01747, United States

University of Minnesota, Dept. of Neurology, Minneapolis, Minnesota 55455, United States

Minnesota Epilepsy Group, PC, St. Paul, Minnesota 55102, United States

Hattiesburg Clinic, Hattiesburg, Mississippi, United States

Ronald Schwartz, M.D., Hattiesburg, Mississippi 39401, United States

The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield, Missouri 63017, United States

Washington University, Saint Louis, Missouri 63110, United States

Saint John's Medical Research, Springfield, Missouri 65807, United States

Saint Louis University, St. Louis, Missouri 63110, United States

Dartmouth Medical School Neuroscience Center, Lebanon, New Hampshire 03756-0001, United States

Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York 10467, United States

Five Towns Neuroscience Research, Lawrence, New York 11559, United States

Columbia University Medical Center, New York, New York 10032, United States

New York University Medical Centre, Comprehensive Epilepsy Center, New York, New York 10016, United States

Weill Cornell Medical Center, Comprehensive Epilepsy Center, New York, New York 10021, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

Asheville Neurology Specialists, PA, Asheville, North Carolina 28806, United States

University of North Carolina at Chapel Hill, Dept. of Neurology, Chapel Hill, North Carolina 27599-7025, United States

Duke Health Center at Morreene Road, Durham, North Carolina 27710, United States

Cleveland Clinic Foundation, Dept. of Neurology, Cleveland, Ohio 44195, United States

Ohio State University, Columbus, Ohio 43210, United States

Medical University of Ohio at Toledo, Dept. of Neurology, Toledo, Ohio 43614, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Blair Medical Associates, Inc., Altoona, Pennsylvania 16602, United States

Hospital of The University of Pennsylvania, Philadelphia, Pennsylvania 19104-4204, United States

Hospital of the University of Pennsylvania, Dept. of Neurology, Philadelphia, Pennsylvania 19104-4283, United States

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Children's Hospital of Pittsburgh - Dept of Pediatrics, Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Mid-South Physicians Group, PLLC, Germantown, Tennessee 38138, United States

University of Tennessee Health Sciences Center, Dept. of Neurology, Memphis, Tennessee 38105, United States

UT Medical Group, Memphis, Tennessee, United States

Access Clinical Trials, Inc, Nashville, Tennessee 37203, United States

Neurological Clinic of Texas, PA, Dallas, Texas 75230, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9034, United States

Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry, El Paso, Texas 79905, United States

University of Texas - Dept of Neurology, Houston, Texas, United States

Baylor Medical Center of Irving, Irving, Texas 75061, United States

Epilepsy and Neurodevelopment, Inc., West Jordan, Utah 84088, United States

Fletcher Allen Healthcare, Burlington, Vermont, United States

University of Vermont, College of Medicine, Clinical Neurophysiology Lab, Burlington, Vermont '05401, United States

Virginia Commonwealth University, Richmond, Virginia 23298-0211, United States

University of Washington, Harborview Medical Center, Regional Epilepsy Center, Seattle, Washington 98105, United States

University of Wisconsin, Dept. of Neurology, Madison, Wisconsin 53792, United States

Additional Information

Starting date: February 2006
Last updated: January 2, 2013

Page last updated: August 23, 2015

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