Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00056576
• Date of registration: 18/03/2003
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
• Scientific title: 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
• Date of first enrolment: February 2002
• Target sample size: 165
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00056576
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Estonia, Hungary, Lithuania, Ukraine, United States

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy, Complex Partial

Intervention(s)

Drug: Zonisamide

Secondary ID(s)

AN46046-304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors