Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

Completed · Phase 3

Conditions studied: Epilepsy, Complex Partial

In brief

The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.

Key facts

Study ID

NCT00056576

Run by

Eisai Inc.

People needed

165

Starts

2002-02-01

Expected to finish

2004-10-01

Last updated by the study team

2011-07-18

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Neurology & Headache Specialist of Atlanta, LLC — Decatur, Georgia, United States
• Southern Illinois University School of Medicine Dept. of Neurology — Springfield, Illinois, United States
• Louisville Neuroscience Research Center — Louisville, Kentucky, United States
• St. Agnes Health Care, Inc. — Baltimore, Maryland, United States
• The Comprehensive Epilepsy Care Center — Chesterfield, Missouri, United States
• Upstate Clinical Research Center — Albany, New York, United States
• Dent Neurological Institute — Orchard Park, New York, United States
• Epilepsy Institute of North Carolina — Winston-Salem, North Carolina, United States
• River Hills Health Care — Cincinnati, Ohio, United States
• Westmoreland Neurology Associates, Inc. — Greensburg, Pennsylvania, United States
• CNS Research, INC — East Providence, Rhode Island, United States
• Neurology Clinic of San Antonio — San Antonio, Texas, United States
• Blue Ridge Research Center — Roanoke, Virginia, United States
• Neurology & Neurosurgery Associates of Tacoma, Inc. P.S. — Tacoma, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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