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

Eisai Inc.0 sites295 target enrollmentOctober 2008

ConditionsEpilepsy

InterventionsZonisamide Carbamazepine

DrugsZonisamide Carbamazepine

Overview

Phase: Phase 3
Intervention: Zonisamide
Conditions: Epilepsy
Sponsor: Eisai Inc.
Enrollment: 295
Primary Endpoint: Percentage of Participants Remaining in the Study at Each Visit
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

November 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has completed study E2090-E044-
•Subject is able and willing to give written informed consent.
•Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects of childbearing potential must be non-pregnant, non-lactating and abide by one of the following medically acceptable contraceptive measures: oral contraceptive pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months, vasectomised partner or abstinence throughout the study and for one month after discontinuation of study medication. When the contraceptive pill is used, this should contain no less than 50 μg oestrogen.
•The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.

Exclusion Criteria

•Subject has a history of a significant or currently uncontrolled disease that will contraindicate the use of the study drugs or interfere with the conduct of this study and/or the assessment of safety and efficacy of the study drugs.
•Subject has a body weight \<40 kg.
•Subject has a newly occurring progressive malignancy during study E2090-E044-310 (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
•Subject has developed a psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months and is considered uncontrolled; history of suicide attempt, alcohol or drug abuse, chronic treatment with benzodiazepines or barbiturates.
•Subject is currently taking carbonic anhydrase inhibitors.
•Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-
•Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
•Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
•Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.

Arms & Interventions

ZNS

Intervention: Zonisamide

CBZ

Intervention: Carbamazepine

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Time to Drop-out Due to Lack of Efficacy(Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study))
Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase(Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase))
Time to Drop-out Due to Adverse Event (AE)(Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study))
Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit(Weeks 0, 26, 52, 78 and 117)