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Trial record 15 of 18 for:    ( Map: Montenegro )

Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

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ClinicalTrials.gov Identifier: NCT00848549
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : January 15, 2013
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Zonisamide
Drug: Carbamazepine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
E2090-E044-314 is a double-blind extension of E2090-E044-310 (NCT00477295) “base study.” Assessment of eligibility took place at the Study Entry Visit (SEV), which was the same day as their final visit of Study 310. Subjects remained on the same investigational product as they were randomized to in Study 310 until unblinding of that 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 Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Carbamazepine Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.

Participant Flow for 3 periods

Period 1:   E2090-E044-310 (Base Study) Disposition
    Zonisamide   Carbamazepine
STARTED   282   301 
COMPLETED   161   192 
NOT COMPLETED   121   109 
Adverse Event                31                35 
Withdrawal by Subject                35                24 
Lack of Efficacy                23                23 
Protocol Violation                3                8 
Physician Decision                4                5 
Lost to Follow-up                21                11 
Not Specified                4                3 

Period 2:   E2090-E044-310 (Base Study) Transition
    Zonisamide   Carbamazepine
STARTED   161   192 
COMPLETED   137   158 
NOT COMPLETED   24   34 
Chose not to enter 314 Extension study                24                34 

Period 3:   E2090-E044-314 (Extension Study)
    Zonisamide   Carbamazepine
STARTED   137   158 
COMPLETED   120   134 
NOT COMPLETED   17   24 
Adverse Event                2                1 
Protocol Violation                1                2 
Withdrawal by Subject                8                12 
Lack of Efficacy                1                1 
Physician Decision                0                2 
Not Specified                5                6 



  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 Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Carbamazepine Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Total Total of all reporting groups

Baseline Measures
   Zonisamide   Carbamazepine   Total 
Overall Participants Analyzed 
[Units: Participants]
 282   301   583 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Base Study 310 (NCT00477295, n=583)   37.1  (16.33)   35.6  (15.50)   36.35  (15.92) 
Extension Study 314 (NCT00848549, n=295)   37.8  (16.13)   34.4  (14.93)   36.1  (15.53) 
Gender, Customized 
[Units: Participants]
     
Female (Base Study 310, NCT00477295)   107   128   235 
Male (Base Study 310, NCT00477295)   174   172   346 
Female (Extension Study 314, NCT00848549)   57   59   116 
Male (Extension Study 314, NCT00848549)   80   99   179 


  Outcome Measures

1.  Primary:   Percentage of Participants Remaining in the Study at Each Visit   [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months ]

2.  Secondary:   Time to Drop-out Due to Lack of Efficacy   [ Time Frame: Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study) ]

3.  Secondary:   Time to Drop-out Due to Adverse Event (AE)   [ Time Frame: Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study) ]

4.  Secondary:   Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase   [ Time Frame: Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase) ]

5.  Secondary:   Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit   [ Time Frame: Weeks 0, 26, 52, 78 and 117 ]


  Serious Adverse Events


  Other Adverse Events


  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

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.
ClinicalTrials.gov Identifier: NCT00848549     History of Changes
Other Study ID Numbers: E2090-E044-314
2008-001159-23 ( EudraCT Number )
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: November 12, 2012
Results First Posted: January 15, 2013
Last Update Posted: December 24, 2015