Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
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
1 other identifier
interventional
165
5 countries
35
Brief Summary
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2002
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 18, 2003
CompletedFirst Posted
Study publicly available on registry
March 19, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedJuly 18, 2011
July 1, 2011
2.7 years
March 18, 2003
July 14, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (35)
UAB Epilepsy Center
Birmingham, Alabama, 35294, United States
North Alabama Neuroscience
Huntsville, Alabama, 35801, United States
Neurology Clinic, P.C.
Northport, Alabama, 35476, United States
Northridge Neurological Center
Northridge, California, 91325, United States
Coordinated Clinical Research
San Diego, California, 92037, United States
Neurology Associates
Maitland, Florida, 32751, United States
Bay Neurological Institute
Panama City, Florida, 32405, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701, United States
AMO Corporation
Tallahassee, Florida, 32308, United States
Florida Epilepsy & Seizure Disorder Center, PA
Tampa, Florida, 33613, United States
Neurology & Headache Specialist of Atlanta, LLC
Decatur, Georgia, 30033, United States
Southern Illinois University School of Medicine Dept. of Neurology
Springfield, Illinois, 62707, United States
Louisville Neuroscience Research Center
Louisville, Kentucky, 40205, United States
St. Agnes Health Care, Inc.
Baltimore, Maryland, 21229, United States
The Comprehensive Epilepsy Care Center
Chesterfield, Missouri, 63017, United States
Upstate Clinical Research Center
Albany, New York, 12205, United States
Dent Neurological Institute
Orchard Park, New York, 14127, United States
Epilepsy Institute of North Carolina
Winston-Salem, North Carolina, 27103, United States
River Hills Health Care
Cincinnati, Ohio, 45219, United States
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, 15601, United States
CNS Research, INC
East Providence, Rhode Island, 02914, United States
Neurology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Blue Ridge Research Center
Roanoke, Virginia, 24014, United States
Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Tallinn Children's Hospital
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 13419, Estonia
Semmelweis University Health Science Faculty
Budapest, 116, Hungary
National Institute of Neurosurgery Epilepsy Center
Budapest, H1145, Hungary
Kaunas Medical University Clinics
Kaunas, 3007, Lithuania
Vilnius University Hospital
Vilnius, 2600, Lithuania
Kharkov State Medical University
Kharkiv, 31002, Ukraine
Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
Kharkiv, 31068, Ukraine
Epilepsy Center
Kiev, 254655, Ukraine
Odessa Medical University
Odesa, 9, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2003
First Posted
March 19, 2003
Study Start
February 1, 2002
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
July 18, 2011
Record last verified: 2011-07