- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00056576
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
14 juli 2011 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning
165
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Tallinn, Estland, 13419
- Tallinn Children's Hospital
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Tartu, Estland, 13419
- Tartu University Hospital
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- UAB Epilepsy Center
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Huntsville, Alabama, Förenta staterna, 35801
- North Alabama Neuroscience
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Northport, Alabama, Förenta staterna, 35476
- Neurology Clinic, P.C.
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California
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Northridge, California, Förenta staterna, 91325
- Northridge Neurological Center
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San Diego, California, Förenta staterna, 92037
- Coordinated Clinical Research
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Florida
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Maitland, Florida, Förenta staterna, 32751
- Neurology Associates
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Panama City, Florida, Förenta staterna, 32405
- Bay Neurological Institute
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St. Petersburg, Florida, Förenta staterna, 33701
- Suncoast Neuroscience Associates, Inc.
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Tallahassee, Florida, Förenta staterna, 32308
- AMO Corporation
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Tampa, Florida, Förenta staterna, 33613
- Florida Epilepsy & Seizure Disorder Center, PA
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Georgia
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Decatur, Georgia, Förenta staterna, 30033
- Neurology & Headache Specialist of Atlanta, LLC
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Illinois
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Springfield, Illinois, Förenta staterna, 62707
- Southern Illinois University School of Medicine Dept. of Neurology
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40205
- Louisville Neuroscience Research Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21229
- St. Agnes Health Care, Inc.
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Missouri
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Chesterfield, Missouri, Förenta staterna, 63017
- The Comprehensive Epilepsy Care Center
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New York
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Albany, New York, Förenta staterna, 12205
- Upstate Clinical Research Center
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Orchard Park, New York, Förenta staterna, 14127
- Dent Neurological Institute
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27103
- Epilepsy Institute of North Carolina
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- River Hills Health Care
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Pennsylvania
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Greensburg, Pennsylvania, Förenta staterna, 15601
- Westmoreland Neurology Associates, Inc.
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Rhode Island
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East Providence, Rhode Island, Förenta staterna, 02914
- CNS Research, INC
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Texas
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San Antonio, Texas, Förenta staterna, 78229
- Neurology Clinic of San Antonio
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Virginia
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Roanoke, Virginia, Förenta staterna, 24014
- Blue Ridge Research Center
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Washington
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Tacoma, Washington, Förenta staterna, 98405
- Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin
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Kaunas, Litauen, 3007
- Kaunas Medical University Clinics
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Vilnius, Litauen, 2600
- Vilnius University Hospital
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Kharkov, Ukraina, 31002
- Kharkov State Medical University
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Kharkov, Ukraina, 31068
- Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
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Kiev, Ukraina, 254655
- Epilepsy Center
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Odessa, Ukraina, 9
- Odessa Medical University
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Budapest, Ungern, 116
- Semmelweis University Health Science Faculty
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Budapest, Ungern, H1145
- National Institute of Neurosurgery Epilepsy Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Dubbel
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2002
Primärt slutförande (Faktisk)
1 oktober 2004
Avslutad studie (Faktisk)
1 oktober 2004
Studieregistreringsdatum
Först inskickad
18 mars 2003
Först inskickad som uppfyllde QC-kriterierna
18 mars 2003
Första postat (Uppskatta)
19 mars 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 juli 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juli 2011
Senast verifierad
1 juli 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Epilepsi, partiell
- Epilepsi
- Epilepsi, komplex partiell
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Membrantransportmodulatorer
- Antikonvulsiva medel
- Kalciumreglerande hormoner och medel
- Kalciumkanalblockerare
- Zonisamid
Andra studie-ID-nummer
- AN46046-304
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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Kliniska prövningar på Zonisamide
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Eisai Inc.Avslutad
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Mutual Pharmaceutical Company, Inc.Avslutad
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University of PittsburghEisai Inc.Indragen
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Mutual Pharmaceutical Company, Inc.Avslutad
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Elan PharmaceuticalsAvslutadMigrän huvudvärkFörenta staterna
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Elan PharmaceuticalsAvslutadBipolära sjukdomar
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Eisai Korea Inc.AvslutadEpilepsiKorea, Republiken av
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Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)AvslutadNikotinberoendeFörenta staterna
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Eisai Inc.AvslutadPartiella anfallTyskland, Sverige, Norge, Österrike, Danmark
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Ain Shams UniversityAvslutadParkinsons sjukdomEgypten