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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00292461

First received: February 14, 2006

Last updated: May 13, 2013

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2006

Last Updated Date

May 13, 2013

Start Date ^ICMJE

March 2006

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment

Original Primary Outcome Measures ^ICMJE

The percentage change of monthly seizure frequency at the end of 16-week treatment from baseline.

Change History

Complete list of historical versions of study NCT00292461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline. [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

1. Response rate: defined as the percentage of subjects with >= 50% reduction of monthly seizure frequency at the end of 16-week treatment from baseline.
2. Global assessment of efficacy by physician at the end of 16-week treatment.
3. Global assessment of safety by subjects at the end of 16-week treatment.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: Zonisamide
Tablet once or twice daily orally for 16 weeks
Drug: Lamotrigine
Tablet once daily orally for 16 weeks

Study Arm (s)

Active Comparator: zonisamide
tablet

Intervention: Drug: Zonisamide
Active Comparator: lamotrigine
tablet

Intervention: Drug: Lamotrigine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00292461

Other Study ID Numbers ^ICMJE

E2090-AS886-202

Has Data Monitoring Committee

Not Provided

Responsible Party

Eisai Inc.

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Ya-Hui Cheng

Eisai Taiwan

Information Provided By

Eisai Inc.

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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