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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:
ClinicalTrials.gov Identifier:
NCT01136954
First Posted: June 4, 2010
Last Update Posted: January 25, 2016
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.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
Results First Submitted: November 12, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Partial Seizures
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
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
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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(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 
Overall Participants Analyzed 
[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
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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: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743



Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01136954     History of Changes
Other Study ID Numbers: E2090-E044-313
2007-000198-53 ( EudraCT Number )
First Submitted: May 26, 2010
First Posted: June 4, 2010
Results First Submitted: November 12, 2012
Results First Posted: February 6, 2013
Last Update Posted: January 25, 2016



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