Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
- Conditions
- Epilepsy, Complex Partial
- Registration Number
- NCT00056576
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
- Detailed Description
Epilepsy is characterized by repeated seizures caused by recurrent, abnormal, and excessive synchronous discharges from cerebral neurons. Seizures may be triggered by various causes such as CNS infections, fever, tumors, toxins, vascular disease, degenerative disease, trauma, or may be idiopathic. The type of seizure is usually defined by the initial event, the duration, alterations of consciousness, patterns of motor activity, and post-ictal symptoms. In addition, certain seizure types have characteristic EEG patterns. The International Classification of Epileptic Seizures classifies seizures as partial or generalized. Partial seizures are further classified as simple partial, complex partial (impaired consciousness), or partial seizures secondarily generalized. All partial seizures have onset in a discrete cortical region. Generalized seizures are bilaterally symmetrical and without focal onset and include absence seizures, myoclonic seizures, clonic seizures, tonic seizures, tonic-clonic seizures, and atonic seizures. The goals of treatment include the prevention of seizures, medical management of seizures, and management of the consequences of epilepsy. The study will be conducted with patients who have new onset epilepsy characterized by complex partial seizures and will attempt to characterize the relationship between zonisamide dose and seizure prevention and demonstrate monotherapy efficacy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Suncoast Neuroscience Associates, Inc.
🇺🇸St. Petersburg, Florida, United States
AMO Corporation
🇺🇸Tallahassee, Florida, United States
Florida Epilepsy & Seizure Disorder Center, PA
🇺🇸Tampa, Florida, United States
National Institute of Neurosurgery Epilepsy Center
🇭🇺Budapest, Hungary
Tartu University Hospital
🇪🇪Tartu, Estonia
Kaunas Medical University Clinics
🇱🇹Kaunas, Lithuania
Vilnius University Hospital
🇱🇹Vilnius, Lithuania
Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
🇺🇦Kharkov, Ukraine
Neurology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
UAB Epilepsy Center
🇺🇸Birmingham, Alabama, United States
Coordinated Clinical Research
🇺🇸San Diego, California, United States
River Hills Health Care
🇺🇸Cincinnati, Ohio, United States
Westmoreland Neurology Associates, Inc.
🇺🇸Greensburg, Pennsylvania, United States
Northridge Neurological Center
🇺🇸Northridge, California, United States
Neurology Associates
🇺🇸Maitland, Florida, United States
North Alabama Neuroscience
🇺🇸Huntsville, Alabama, United States
Neurology Clinic, P.C.
🇺🇸Northport, Alabama, United States
Bay Neurological Institute
🇺🇸Panama City, Florida, United States
Neurology & Headache Specialist of Atlanta, LLC
🇺🇸Decatur, Georgia, United States
St. Agnes Health Care, Inc.
🇺🇸Baltimore, Maryland, United States
Louisville Neuroscience Research Center
🇺🇸Louisville, Kentucky, United States
The Comprehensive Epilepsy Care Center
🇺🇸Chesterfield, Missouri, United States
Southern Illinois University School of Medicine Dept. of Neurology
🇺🇸Springfield, Illinois, United States
CNS Research, INC
🇺🇸East Providence, Rhode Island, United States
Upstate Clinical Research Center
🇺🇸Albany, New York, United States
Dent Neurological Institute
🇺🇸Orchard Park, New York, United States
Epilepsy Institute of North Carolina
🇺🇸Winston-Salem, North Carolina, United States
Blue Ridge Research Center
🇺🇸Roanoke, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
🇺🇸Tacoma, Washington, United States
Semmelweis University Health Science Faculty
🇭🇺Budapest, Hungary
Tallinn Children's Hospital
🇪🇪Tallinn, Estonia
Kharkov State Medical University
🇺🇦Kharkov, Ukraine
Epilepsy Center
🇺🇦Kiev, Ukraine
Odessa Medical University
🇺🇦Odessa, Ukraine