Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier:
NCT01140867
First received: May 19, 2010
Last updated: September 8, 2011
Last verified: May 2011
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: zonisamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was recruited at 10 centers in Korea during the period of February 2008 to August 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zonisamide Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.

Participant Flow:   Overall Study
    Zonisamide  
STARTED     121  
COMPLETED     88  
NOT COMPLETED     33  
Adverse Event                 22  
Lack of Efficacy                 3  
Lost to Follow-up                 2  
Withdrawal by Subject                 1  
Protocol Violation                 1  
Uncooperative patient                 2  
Medication Noncompliance                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zonisamide Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.

Baseline Measures
    Zonisamide  
Number of Participants  
[units: participants]
  121  
Age  
[units: years]
Mean ± Standard Deviation
  37.70  ± 11.19  
Gender  
[units: participants]
 
Female     52  
Male     69  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     121  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     0  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seizure Reduction Rate   [ Time Frame: Baseline and 16 weeks ]

2.  Secondary:   Seizure Free Rate   [ Time Frame: 16 weeks ]

3.  Secondary:   Responder Rate   [ Time Frame: Baseline and 16 weeks ]

4.  Secondary:   QoL-QOLIE31 (Quality of Life in Epilepsy)   [ Time Frame: Baseline and 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jihee Mun, Pharmacist, Medical Department manager
Organization: Eisai Korea Inc.
phone: +82-2-3451-5531
e-mail: jihee_mun@eisaikorea.com


No publications provided


Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT01140867     History of Changes
Other Study ID Numbers: E2090-S082-409
Study First Received: May 19, 2010
Results First Received: August 5, 2011
Last Updated: September 8, 2011
Health Authority: KFDA: Korea