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

Eisai

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: Lamotrigine

Drug: Zonisamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00292461

E2090-AS886-202

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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