NCT00848549

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Zonisamide	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.
DRUG	Carbamazepine	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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-06-01
• Completion: 2011-11-01
• First posted: 2009-02-20
• Last updated: 2015-12-24
• Results posted: 2013-01-15

Locations

133 sites across 20 countries: Australia, Denmark, France, Germany, Greece, Hungary, India, Italy, Montenegro, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom