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

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: 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. )

Tracking Information
First Submitted Date  ICMJE May 19, 2010
First Posted Date  ICMJE May 20, 2010
Results First Submitted Date  ICMJE August 2, 2010
Results First Posted Date  ICMJE July 26, 2012
Last Update Posted Date July 26, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
The Percentage of Participants With Seizure Free Rate [ Time Frame: 24 weeks ]
The percentage of participants who had no seizure during the trial.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2010)
Seizure free rate [ Time Frame: Baseline, 4, 8, 12, 16, 25~27 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
  • The Percentage of Participants With Retention Rate [ Time Frame: 24 weeks ]
    The percentage of participants who completed the trial.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2010)
Quality of life assessment [ Time Frame: Baseline, 25~27 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Official Title  ICMJE Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: zonisamide
    Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
  • Drug: carbamazepine
    Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: zonisamide
  • Active Comparator: 2
    Intervention: Drug: carbamazepine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2010)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01127256
Other Study ID Numbers  ICMJE E2090-S082-405
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Korea Inc. )
Study Sponsor  ICMJE Eisai Korea Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jihee Mun Medical Department, Eisai Korea Inc.
PRS Account Eisai Inc.
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP