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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zonisamide

tablet

Group Type ACTIVE_COMPARATOR

Zonisamide

Intervention Type DRUG

Tablet once or twice daily orally for 16 weeks

lamotrigine

tablet

Group Type ACTIVE_COMPARATOR

Lamotrigine

Intervention Type DRUG

Tablet once daily orally for 16 weeks

Interventions

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Zonisamide

Tablet once or twice daily orally for 16 weeks

Intervention Type DRUG

Lamotrigine

Tablet once daily orally for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No