Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Zonisamide

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