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

NCT00154076 | Completed Phase 4

• 1 other identifier: E2090-S082-403
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

  2, 4, 8, 12, 16, 20, 24 weeks

Secondary Outcomes (1)

• Cognitive function

  0, 24 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Zonisamide

2

ACTIVE COMPARATOR

Drug: Topiramate

Interventions

Zonisamide DRUG

Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.

Also known as: Zonegran

1

Topiramate DRUG

Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.

2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, South Korea

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Zonisamide; Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Jihee Mun

  Eisai Korea Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 2, 2009

Record last verified: 2009-08

Locations

KR (1)