We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Sponsor's decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693017
First Posted: June 6, 2008
Last Update Posted: December 24, 2015
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: August 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Zonisamide
Drug: Placebo

  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
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
  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

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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) ]

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


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


  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: Antonio Laurenza, MD, Executive Director
Organization: Eisai Inc
phone: 1 201 949-4157
e-mail: antonio_laurenza@eisai.com



Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT00693017     History of Changes
Other Study ID Numbers: E2090-E044-317
2007-003556-10 ( EudraCT Number )
First Submitted: June 3, 2008
First Posted: June 6, 2008
Results First Submitted: August 13, 2012
Results First Posted: September 12, 2012
Last Update Posted: December 24, 2015