Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
|ClinicalTrials.gov Identifier: NCT00848549|
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : January 15, 2013
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Zonisamide Drug: Carbamazepine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||295 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||November 2011|
|Active Comparator: ZNS||
Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.
Other Name: Zonegran
|Active Comparator: CBZ||
Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
- Percentage of Participants Remaining in the Study at Each Visit [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months ]The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.
- 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) ]Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.
- 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) ]
Adverse events in study subjects included any change in the subject's condition.
This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF).
- 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) ]The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.
- 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 ]The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848549
|Principal Investigator:||Michel Baulac||Hopital de la Pitie-Saltpetriere|