Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
14 de julio de 2011 actualizado por: Eisai Inc.
A Double-Blind, Randomized, Multicenter, Parallel Group Study to Establish Dose-Response, Safety, and Efficacy of Zonegran (Zonisamide) as Monotherapy in Patients With Newly Diagnosed Epilepsy
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción
165
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- UAB Epilepsy Center
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Huntsville, Alabama, Estados Unidos, 35801
- North Alabama Neuroscience
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Northport, Alabama, Estados Unidos, 35476
- Neurology Clinic, P.C.
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California
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Northridge, California, Estados Unidos, 91325
- Northridge Neurological Center
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San Diego, California, Estados Unidos, 92037
- Coordinated Clinical Research
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Florida
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Maitland, Florida, Estados Unidos, 32751
- Neurology Associates
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Panama City, Florida, Estados Unidos, 32405
- Bay Neurological Institute
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St. Petersburg, Florida, Estados Unidos, 33701
- Suncoast Neuroscience Associates, Inc.
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Tallahassee, Florida, Estados Unidos, 32308
- AMO Corporation
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Tampa, Florida, Estados Unidos, 33613
- Florida Epilepsy & Seizure Disorder Center, PA
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Georgia
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Decatur, Georgia, Estados Unidos, 30033
- Neurology & Headache Specialist of Atlanta, LLC
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Illinois
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Springfield, Illinois, Estados Unidos, 62707
- Southern Illinois University School of Medicine Dept. of Neurology
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40205
- Louisville Neuroscience Research Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21229
- St. Agnes Health Care, Inc.
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Missouri
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Chesterfield, Missouri, Estados Unidos, 63017
- The Comprehensive Epilepsy Care Center
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New York
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Albany, New York, Estados Unidos, 12205
- Upstate Clinical Research Center
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Orchard Park, New York, Estados Unidos, 14127
- Dent Neurological Institute
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Epilepsy Institute of North Carolina
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- River Hills Health Care
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Pennsylvania
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Greensburg, Pennsylvania, Estados Unidos, 15601
- Westmoreland Neurology Associates, Inc.
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02914
- CNS Research, INC
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Neurology Clinic of San Antonio
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Virginia
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Roanoke, Virginia, Estados Unidos, 24014
- Blue Ridge Research Center
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin
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Tallinn, Estonia, 13419
- Tallinn Children's Hospital
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Tartu, Estonia, 13419
- Tartu University Hospital
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Budapest, Hungría, 116
- Semmelweis University Health Science Faculty
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Budapest, Hungría, H1145
- National Institute of Neurosurgery Epilepsy Center
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Kaunas, Lituania, 3007
- Kaunas Medical University Clinics
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Vilnius, Lituania, 2600
- Vilnius University Hospital
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Kharkov, Ucrania, 31002
- Kharkov State Medical University
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Kharkov, Ucrania, 31068
- Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
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Kiev, Ucrania, 254655
- Epilepsy Center
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Odessa, Ucrania, 9
- Odessa Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2002
Finalización primaria (Actual)
1 de octubre de 2004
Finalización del estudio (Actual)
1 de octubre de 2004
Fechas de registro del estudio
Enviado por primera vez
18 de marzo de 2003
Primero enviado que cumplió con los criterios de control de calidad
18 de marzo de 2003
Publicado por primera vez (Estimar)
19 de marzo de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de julio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
14 de julio de 2011
Última verificación
1 de julio de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Epilepsias Parciales
- Epilepsia
- Epilepsia Parcial Compleja
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Moduladores de transporte de membrana
- Anticonvulsivos
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Zonisamida
Otros números de identificación del estudio
- AN46046-304
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .