NCT00848549已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 295
- 主要终点
- Percentage of Participants Remaining in the Study at Each Visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ZNS
Active Comparator
干预措施: Zonisamide (Drug)
CBZ
Active Comparator
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Percentage of Participants Remaining in the Study at Each Visit
时间窗: 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.
次要结局
- 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)
研究者
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