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Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

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ClinicalTrials.gov Identifier: NCT01127256
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : July 26, 2012
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )

Brief Summary:
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: zonisamide Drug: carbamazepine Phase 4

Detailed Description:
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Study Start Date : May 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 1 Drug: zonisamide
Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.

Active Comparator: 2 Drug: carbamazepine
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.




Primary Outcome Measures :
  1. The Percentage of Participants With Seizure Free Rate [ Time Frame: 24 weeks ]
    The percentage of participants who had no seizure during the trial.


Secondary Outcome Measures :
  1. The Percentage of Participants With Retention Rate [ Time Frame: 24 weeks ]
    The percentage of participants who completed the trial.

  2. Quality of Life in Epilepsy (QoL-QOLIE31) [ Time Frame: 24 weeks ]
    Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Epilepsy patients over 15 years old.
  2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
  3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
  4. Female who can be in the month of pregnancy should agree to prevent conception.
  5. Patients who agree with Informed Consent Form.

Exclusion criteria:

  1. Patients who have Myoclonic seizures and/or Absence seizures.
  2. Patients who have progressive central nervous system (CNS) disorder.
  3. Patients who have serious systemic disorder.
  4. Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
  5. Patients who have renal stones.
  6. Medical history of medicinal poisoning and/or alcoholism.
  7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.

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): NCT01127256


Locations
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Korea, Republic of
Seoul National Univ. Bundang Hosp.
Bundang, Korea, Republic of
Chungnam National Univ. Hosp.
Chungnam, Korea, Republic of
Dongguk Univ. Ilsan Hosp.
Ilsan, Korea, Republic of
Inha Univ. Hosp.
Incheon, Korea, Republic of
Boramae Medical Center
Seoul, Korea, Republic of
Eulji General Hosp.
Seoul, Korea, Republic of
Ewha Womans Univ. Mokdong Hospital
Seoul, Korea, Republic of
Hallym Univ. Medical Center
Seoul, Korea, Republic of
Hanyang Univ. Medical Center
Seoul, Korea, Republic of
Konkuk Univ. Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National Univ. Hosp.
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.
Investigators
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Study Director: Jihee Mun Medical Department, Eisai Korea Inc.

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Responsible Party: Eisai Korea Inc.
ClinicalTrials.gov Identifier: NCT01127256     History of Changes
Other Study ID Numbers: E2090-S082-405
First Posted: May 20, 2010    Key Record Dates
Results First Posted: July 26, 2012
Last Update Posted: July 26, 2012
Last Verified: May 2010

Additional relevant MeSH terms:
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Carbamazepine
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers