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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00154076
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Eisai Inc.

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Zonisamide Drug: Topiramate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 1 Drug: Zonisamide
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
Other Name: Zonegran

Active Comparator: 2 Drug: Topiramate
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.




Primary Outcome Measures :
  1. Seizure frequency [ Time Frame: 2, 4, 8, 12, 16, 20, 24 weeks ]

Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: 0, 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154076


Locations
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Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.
Investigators
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Study Director: Jihee Mun Eisai Korea Inc.
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Responsible Party: Jihee Mun, Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT00154076    
Other Study ID Numbers: E2090-S082-403
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 2, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Zonisamide
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents