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