Overview

A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eisai Inc.
Treatments:
Anticonvulsants
Lamotrigine
Zonisamide
Criteria
Inclusion criteria:

- Subjects must sign and date the informed consent form

- Clinical diagnosis as refractory epilepsy

Exclusion criteria:

- Progressive neurologic disease

- Serious psychiatric disease

- Hemolytic anemia

- G6PD (glucose-6-phosphate dehydrogenase) deficiency

- Acute intermittent porphyrias

- Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past

- Drug or alcohol addiction

- Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST >
2x ULN)

- Stevens-Johnson syndrome

- Progressive exfoliative dermatitis

- Pregnant, lactating or of childbearing potential female

- Regularly taking oral contraceptives

- Hypersensitivity to study drugs

- Severe cardiac disease (New York Heart Association Functional Class III and IV)

- History of malignancy within 5 years

- Taking valproic acid within 7 days prior to screening

- Subjects with simple partial seizures without motor component