The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
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UAB Epilepsy Center
Birmingham, Alabama, United States
North Alabama Neuroscience
Huntsville, Alabama, United States
Neurology Clinic, P.C.
Northport, Alabama, United States
Northridge Neurological Center
Northridge, California, United States
Coordinated Clinical Research
San Diego, California, United States
Neurology Associates
Maitland, Florida, United States
Bay Neurological Institute
Panama City, Florida, United States
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
...and 25 more locations