A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01136954
First received: May 26, 2010
Last updated: June 26, 2014
Last verified: January 2013
Results First Received: November 12, 2012  
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: Partial Seizures
Intervention: Drug: Zonisamide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects who completed E2090-E044-312 (NCT00566254)"Study 312" core study were invited to participate in this extension study.

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(Placebo During Core Study) Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
Zonisamide (Zonisamide During Core Study) Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.

Participant Flow:   Overall Study
    Zonisamide(Placebo During Core Study)     Zonisamide (Zonisamide During Core Study)  
STARTED     72     72  
COMPLETED     48     51  
NOT COMPLETED     24     21  
Adverse Event                 3                 2  
Withdrawal by Subject                 6                 2  
Lack of Efficacy                 14                 13  
Physician Decision                 0                 1  
Not Specified                 1                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

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(Placebo During Core Study) Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
Zonisamide (Zonisamide During Core Study) Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
Total Total of all reporting groups

Baseline Measures
    Zonisamide(Placebo During Core Study)     Zonisamide (Zonisamide During Core Study)     Total  
Number of Participants  
[units: participants]
  72     72     144  
Age, Customized  
[units: Participants]
     
6-11 Years     34     33     67  
12-18 Years     38     39     77  
Gender  
[units: participants]
     
Female     32     41     73  
Male     40     31     71  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency   [ Time Frame: Week 1 through Week 59 ]

2.  Secondary:   Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period   [ Time Frame: Baseline through Week 59 ]

3.  Secondary:   Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period   [ Time Frame: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313 ]

4.  Secondary:   Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period   [ Time Frame: Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


No publications provided


Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01136954     History of Changes
Other Study ID Numbers: E2090-E044-313, 2007-000198-53
Study First Received: May 26, 2010
Results First Received: November 12, 2012
Last Updated: June 26, 2014
Health Authority: European Union: Ethics Committee (EC) and CA (Competent Authority?) in 9 European Countries