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Home > "D" Clinical Trials Conditions > Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy  Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
For Condition: Epilepsy, Complex Partial
Status: No longer recruiting
Sponsor(s): Elan Pharmaceuticals ,
Synopsis: The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Patient able and willing to give written informed consent or assent as appropriate in accordance with ICH and GCP guidelines - Patient with newly diagnosed epilepsy who has complex partial seizures (with or without secondary generalization) - Patient must have at least two well-documented, unprovoked, clinically evaluated and classified complex partial seizures or one well-documented, unprovoked, clinically evaluated and classified complex partial seizure and an abnormal EEG consistent with the diagnosis of epilepsy occurring within one year prior to enrollment - Patient must have received less than 2 weeks of prior AED therapy, which will be discontinued at study entry - EEG changes consistent with the diagnosis of epilepsy: · For patients with two well-documented, unprovoked complex partial seizures within one year prior to enrollment, the EEG results may be normal at the time of testing but, in the opinion of the Investigator, the patient has epilepsy · For patients with one well-documented, unprovoked complex partial seizure within one year prior to enrollment, the EEG must be abnormal at the time of testing consistent with the diagnosis of epilepsy - Patient age 16 years or greater - In the opinion of the Investigator, the patient is in good health - Female patients of child-bearing potential must not be pregnant (serum HCG negative) or lactating, and must be using a medically acceptable form of birth control such as abstinence, an adequate barrier method, or hormonal contraceptive; or female patients who are post-menopausal or have had surgical sterilization - Patient or caregiver able to follow Investigator instruction, study procedures, maintain diary of concomitant medication use, and report adverse events EXCLUSION CRITERIA - History of status epilepticus - Patient with simple partial seizures only - A history of non-epileptic seizures (e.g. metabolic or pseudo-seizures) - Progressive encephalopathy or findings consistent with progressive CNS disease or lesions (e.g. infection, demyelination, tumor) - Clinically significant uncontrolled medical disease in the previous two years (including unstable cardiac, hematological, hepatic, or renal disease) - History of acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency or hemolytic anemia - Renal insufficiency (serum creatinine > 2 mg/dL) or impaired liver function (SGPT/ALT > two times upper limit of normal) - History of renal calculi - Laboratory test results which, in the opinion of the Investigator, are clinically significant abnormalities - History of alcohol or drug abuse - Psychiatric illness or mood disorders requiring treatment in previous 6 months; history of suicide attempt or psychosis - Use of benzodiazepines (intermittent use as a hypnotic or an PRN AED is allowed) - Use of other investigational compounds, experimental drugs or devices within 30 days of the screening visit - History of hypersensitivity or allergic reaction to sulfonamides - Medical disorder, surgery or medication that might interfere with absorption, distribution, metabolism, or excretion of the study drug
Total Enrollment: 165
Location and Contact Information:
Neurology Clinic of San Antonio
San Antonio, Texas, 78229
United States
Kaunas Medical University Clinics
Kaunas, , 3007
Lithuania
Southern Illinois University School of Medicine Dept. of Neurology
Springfield, Illinois, 62707
United States
Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
Kharkov, , 31068
Ukraine
Coordinated Clinical Research
San Diego, California, 92037
United States
Blue Ridge Research Center
Roanoke, Virginia, 24014
United States
St. Agnes Health Care, Inc.
Baltimore, Maryland, 21229
United States
Northridge Neurological Center
Northridge, California, 91325
United States
Neurology Clinic, P.C.
Northport, Alabama, 35476
United States
Florida Epilepsy & Seizure Disorder Center, PA
Tampa, Florida, 33613
United States
North Alabama Neuroscience
Huntsville, Alabama, 35801
United States
Epilepsy Institute of North Carolina
Winston Salem, North Carolina, 27103
United States
Dent Neurological Institute
Orchard Park, New York, 14127
United States
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, 15601
United States
National Institute of Neurosurgery Epilepsy Center
Budapest, , H1145
Hungary
River Hills Health Care
Cincinnati, Ohio, 45219
United States
Semmelweis University Health Science Faculty
Budapest, , 116
Hungary
Epilepsy Center
Kiev, , 254655
Ukraine
Odessa Medical University
Odessa, , 9
Ukraine
University of Wisconsin
Madison, Wisconsin, 53792
United States
Neurology & Headache Specialist of Atlanta, LLC
Decatur, Georgia, 30033
United States
Tallinn Children's Hospital
Tallinn, , 13419
Estonia
CNS Research, INC
Providence, Rhode Island, 02914
United States
Neurology Associates
Maitland, Florida, 32751
United States
The Comprehensive Epilepsy Care Center
Chesterfield, Missouri, 63017
United States
Vilnius University Hospital
Vilnius, , 2600
Lithuania
Upstate Clinical Research Center
Albany, New York, 12205
United States
Louisville Neuroscience Research Center
Louisville, Kentucky, 40205
United States
AMO Corporation
Tallahassee, Florida, 32308
United States
Bay Neurological Institute
Panama City, Florida, 32405
United States
Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
Tacoma, Washington, 98405
United States
Kharkov State Medical University
Kharkov, , 31002
Ukraine
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
United States
Tartu University Hospital
Tartu, , 13419
Estonia
UAB Epilepsy Center
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: AN46046-304;
Study Start Date: February 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056576
Other Epilepsy, Complex Partial Studies:
1. Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
2. Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
Related Studies:
Other Epilepsy, Complex Partial Clinical Trials
Other New York Clinical Trials
Other Orchard Park Clinical Trials
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
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