A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01546688
First received: March 2, 2012
Last updated: February 7, 2013
Last verified: February 2013
Results First Received: November 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Zonisamide at targeted daily doses of 100-500 mg/day
Drug: Placebo administered to match targeted daily doses of 100-500 mg/day

  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
No text entered.

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
Placebo Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
Zonisamide Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.

Participant Flow:   Overall Study
    Placebo     Zonisamide  
STARTED     18     33  
COMPLETED     15     28  
NOT COMPLETED     3     5  
Adverse Event                 0                 4  
Withdrawal by Subject                 2                 1  
Lack of Efficacy                 1                 0  



  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
Placebo Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
Zonisamide Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
Total Total of all reporting groups

Baseline Measures
    Placebo     Zonisamide     Total  
Number of Participants  
[units: participants]
  18     33     51  
Age [1]
[units: Years]
Mean ± Standard Deviation
  71.1  ± 4.61     72.5  ± 5.63     72.0  ± 5.29  
Gender [2]
[units: Participants]
     
Female     11     19     30  
Male     7     14     21  
Race/Ethnicity, Customized [3]
[units: Participants]
     
White     18     33     51  
Race/Ethnicity, Customized [4]
[units: Participants]
     
Hispanic or Latino     1     2     3  
Not Hispanic or Latino     17     31     48  
[1] Safety Population
[2] Safety Population: All randomized subjects who received at least one dose of study medication.
[3] Race. Safety Population.
[4] Ethnicity. Safety Population.



  Outcome Measures
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1.  Primary:   Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ]

2.  Primary:   Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ]

3.  Secondary:   Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period   [ Time Frame: Baseline and Month 4 ]

4.  Secondary:   Percentage of Responders During Last 28 Days of Maintenance Period   [ Time Frame: Baseline and Month 4 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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: NCT01546688     History of Changes
Other Study ID Numbers: E2090-E044-402
Study First Received: March 2, 2012
Results First Received: November 12, 2012
Last Updated: February 7, 2013
Health Authority: European Union: European Medicines Agency