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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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Zonisamide
Lamotrigine
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, seizures

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Changhua Christian Hospital
  • Chang-Gung Memorial Hospital (CGMH)
  • Chang-Gung Memorial Hospital (CGMH)
  • China Medical University Hospital (CMUH)
  • National Cheng Kung University Hospital
  • Chang-Gung Memorial Hospital (CGMH)
  • Taipei Tzu Chi General Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

zonisamide

lamotrigine

Arm Description

tablet

tablet

Outcomes

Primary Outcome Measures

The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
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

Secondary Outcome Measures

Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.

Full Information

First Posted
February 14, 2006
Last Updated
May 13, 2013
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00292461
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zonisamide
Arm Type
Active Comparator
Arm Description
tablet
Arm Title
lamotrigine
Arm Type
Active Comparator
Arm Description
tablet
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Intervention Description
Tablet once or twice daily orally for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Intervention Description
Tablet once daily orally for 16 weeks
Primary Outcome Measure Information:
Title
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
Description
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
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Time Frame
Baseline and 16 weeks
Title
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Time Frame
Baseline and 16 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Hui Cheng
Organizational Affiliation
Eisai Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
State/Province
Taiwan
Country
China
Facility Name
Chang-Gung Memorial Hospital (CGMH)
City
Kaohsiung
State/Province
Taiwan
Country
China
Facility Name
Chang-Gung Memorial Hospital (CGMH)
City
Linkou
State/Province
Taiwan
Country
China
Facility Name
China Medical University Hospital (CMUH)
City
Taichun
State/Province
Taiwan
Country
China
Facility Name
National Cheng Kung University Hospital
City
Tainan
State/Province
Taiwan
Country
China
Facility Name
Chang-Gung Memorial Hospital (CGMH)
City
Taipei
State/Province
Taiwan
Country
China
Facility Name
Taipei Tzu Chi General Hospital
City
Taipei
State/Province
Taiwan
Country
China
Facility Name
Taipei Veterans General Hospital
City
Taipei
State/Province
Taiwan
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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