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

May 13, 2013 updated by: Eisai Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Taiwan
      • Changhua, Taiwan, China
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, China
        • Chang-Gung Memorial Hospital (CGMH)
      • Linkou, Taiwan, China
        • Chang-Gung Memorial Hospital (CGMH)
      • Taichun, Taiwan, China
        • China Medical University Hospital (CMUH)
      • Tainan, Taiwan, China
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, China
        • Chang-Gung Memorial Hospital (CGMH)
      • Taipei, Taiwan, China
        • Taipei Tzu Chi General Hospital
      • Taipei, Taiwan, China
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: zonisamide
tablet
Drug: Zonisamide
Tablet once or twice daily orally for 16 weeks
Active Comparator: lamotrigine
tablet
Drug: Lamotrigine
Tablet once daily orally for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
Time Frame: Baseline and 16 weeks
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
Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Time Frame: Baseline and 16 weeks
Baseline and 16 weeks
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Time Frame: Baseline and 16 weeks
Baseline and 16 weeks
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
Baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Ya-Hui Cheng, Eisai Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2090-AS886-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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