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Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

This study has been terminated.
(Sponsor's decision)
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT00693017
First received: June 3, 2008
Last updated: August 13, 2012
Last verified: June 2012
History of Changes
Results First Received: August 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Zonisamide
Drug: Placebo

  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 three study centers (1 in Australia and 2 in Hungary). A further 39 study centers in Europe and Australia were initiated. A total of 12 study sites in the following countries were not initiated; (2 in Finland), (3 in Czech Republic), and (7 in Ukraine) during the period of 04 June 2008 to 05 January 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
10 participants were screened for eligibility and six participants did not continue after the Screening Visit due to the Sponsor's decision to terminate the study. 4 participants were enrolled and treated during the study.

Reporting Groups
  Description
Zonisamide

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)
Placebo

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

Participant Flow:   Overall Study
    Zonisamide     Placebo  
STARTED     2     2  
COMPLETED     0     0  
NOT COMPLETED     2     2  
Sponsor Decision                 2                 1  
Death                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Zonisamide

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)
Placebo

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)
Total Total of all reporting groups

Baseline Measures
    Zonisamide     Placebo     Total  
Number of Participants  
[units: participants]
 		  2     2     4  
Age  
[units: years]
Mean ± Standard Deviation 		  24.0  ± 16.97     33.5  ± 23.33     28.8  ± 17.54  
Gender  
[units: participants]
 		     
Female     1     1     2  
Male     1     1     2  



  Outcome Measures
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1.  Primary:   Number of Participants Considered Responders as Assessed During the Maintenance Period   [ Time Frame: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16) ]
  Show Outcome Measure 1

2.  Secondary:   Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures   [ Time Frame: Baseline and up to 16 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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
Due to early termination of the study by the Sponsor. No formal analyses were conducted.  


Results Point of Contact:  
Name/Title: Antonio Laurenza, MD, Executive Director
Organization: Eisai Inc
phone: 1 201 949-4157
e-mail: antonio_laurenza@eisai.com


No publications provided


Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT00693017     History of Changes
Other Study ID Numbers: E2090-E044-317
Study First Received: June 3, 2008
Results First Received: August 13, 2012
Last Updated: August 13, 2012
Health Authority: European Union: European Medicines Agency