A Multicenter Comparative Trial of Zonisamide and Topiram... | NCT00154076

Studies
A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

NCT00154076

Sponsor

Eisai Korea Inc.

Status

Completed

Last Update Posted

Sep 2, 2009Estimated

Enrollment

140Estimated

Phase

Phase 4

Conditions

Epilepsy

Interventions

Zonisamide
Topiramate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Aug 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2009

Last Update Posted Date

Sep 2, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Zonisamide
2	Active Comparator		Drug: Topiramate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zonisamide	Drug	Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.	1

Measure	Description	Time Frame
Seizure frequency		2, 4, 8, 12, 16, 20, 24 weeks

Measure	Description	Time Frame
Cognitive function		0, 24 weeks

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients over 13 years old (complete the elementary school course).
Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening.
Patients had no antiepileptic drugs for the last 4 months.
Women of childbearing age who agree to contraception during participating this clinical trial.

Exclusion criteria:

Pregnancy
Patients who have progressive neurologic disease
Allergy to sulfonamides
Use of acetazolamide within a year
Hemolytic anemia
Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values.
Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values.
Patients who have history of drug or alcohol abuse.
Glucose-6-phosphate dehydrogenase deficiency.
Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test.
Patients who have progressive internal or surgical disease.
Patients who have progressive psychiatric disease.
Patients who have mental retardation (IQ 70 and less).
Patients taking Vit C.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jihee Mun	Eisai Korea Inc.	Study Director

Type	Date	Date Unknown
Release	Jul 21, 2010
Reset	Aug 17, 2010
Release	Jun 20, 2012
Reset	Jul 25, 2012

ID	Term
D004827	Epilepsy

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000078305	Zonisamide
D000077236	Topiramate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 21, 2010			Aug 17, 2010
Jun 20, 2012