A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
2014年1月23日 更新者：Eisai Inc.
Evaluation of Safety and Efficacy of Zonisamide in Adult Patients With Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational Study
The purpose of this study is to evaluate the safety and efficacy of zonisamide in the treatment of adult patients with partial, generalized or combined seizures.
研究概览
详细说明
This is an open labeled non-comparative, multicentric observational post marketing surveillance study to comparing the safety and efficacy of zonisamide as adjunctive therapy or monotherapy in patients with partial, generalized or combined seizures, in a initiating dose of 100mg/day titrated to a maximum of 600mg per day based on the seizure control and tolerability over a 24 weeks treatment period.
This study will include a total of 900 patients with partial, generalized or combined seizures across 30 centres in the country.
The patients will be enrolled based on the inclusion and exclusion criteria and will be evaluated for safety and efficacy at every 4 weekly interval for 24 weeks.
There will be total 7 study visits and the patients will be evaluated for clinically reportable adverse events, safety on Patients Global Assessment of Tolerability to Therapy (PGATT) on a 4-point scale and for efficacy by evaluation of reduction in seizure frequency as the primary objective of the study.
For secondary objectives the patients data will be evaluated to determine the responder rates (> or = to 50% reduction in seizure frequency from baseline) and seizure freedom over the 24 weeks study period.
研究类型
观察性的
注册 (实际的)
655
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Delhi、印度、110070
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Andhra Pradesh
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Hyderabad、Andhra Pradesh、印度、500016
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Hyderabad、Andhra Pradesh、印度、500027
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Hyderabad、Andhra Pradesh、印度、500057
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Secunderabad、Andhra Pradesh、印度、500003
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Secunderabad、Andhra Pradesh、印度、500015
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Vijaywada、Andhra Pradesh、印度
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Vishakapatnam、Andhra Pradesh、印度
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Vishakhapatnam、Andhra Pradesh、印度、530002
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Gujarat
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Ahmedabad、Gujarat、印度、380009
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Gujrat
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Ahmedabad、Gujrat、印度、380015
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Karanataka
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Bangalore、Karanataka、印度、560010
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Kerela
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Kochi、Kerela、印度、682012
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Kochi、Kerela、印度、682301
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Maharashtra
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Mumbai、Maharashtra、印度、400012
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Mumbai、Maharashtra、印度、400049
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Pune、Maharashtra、印度
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Rajastan
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Jaipur、Rajastan、印度、302004
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Jaipur、Rajastan、印度、302015
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Jaipur、Rajastan、印度、302017
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Tamilnadu
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Chennai、Tamilnadu、印度、500017
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Chennai、Tamilnadu、印度、600006
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Chennai、Tamilnadu、印度、600010
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Chennai、Tamilnadu、印度、600017
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Uttar Pradesh
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Lucknow、Uttar Pradesh、印度、226003
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Lucknow、Uttar Pradesh、印度、226022
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Noida、Uttar Pradesh、印度、201301
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Single Cohort Study involving community patients with epilepsy
描述
Inclusion Criteria:
- Male or female subjects, 18 to 75 years of age inclusive
Treated or untreated subjects suffering from any of the following types of seizures:
- Partial Seizures: Simple Partial Seizures, Complex Partial Seizures & Secondarily generalized tonic clonic seizures
- Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical absence seizures
- Combined seizures (mixed)
- Subjects having had a computed tomography (CT) or magnetic resonance imaging (MRI) done within the last upto 10 years that ruled a progressive cause of epilepsy.
- Female subjects without child bearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible.
- Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and enrollment must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug.
- Patients willing to take the medications as directed, maintain a seizure dairy, report adverse events and willing to come for the follow-ups as per schedule.
- Willing to comply with the protocol requirements.
- Able and willing to give the written informed consent.
Exclusion Criteria:
- Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures).
- Subjects who have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation related seizures.
- Subjects with progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination or tumour).
- Subjects with a history of any significant or currently uncontrolled disease which in the opinion of the investigator will interfere with the conduct of this study or the assessment of safety & efficacy of the study drug.
- Subjects already receiving zonisamide therapy.
- Subjects who have received an investigational new drug or device in the past three months before screening and enrollment.
- Subjects with known hypersensitivity to zonisamide or sulphonamides.
- Subjects with known abnormal renal function (serum creatinine > 1.5 mg/dL) or abnormal hepatic function (Aspartate aminotransferase [AST] and alanine aminotransferase [ALT] > 2 times the upper normal limit).
- Subjects with a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse.
- Subjects currently taking carbonic anhydrase inhibitors (acetazolamide).
- Subjects currently taking Mono-Amine Oxidase Inhibitor's (MAO-I's).
- Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant laboratory abnormalities suggestive of metabolic imbalance
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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实验性的
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zonisamide 100mg tablets
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Assess safety with zonisamide therapy in adult patients with different seizure types
大体时间：24 weeks
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24 weeks
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Assess reduction in seizure frequency with zonisamide therapy in adult patients with different seizure types
大体时间：24 weeks
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24 weeks
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次要结果测量
结果测量 |
大体时间 |
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To evaluate responder rates over 24 weeks of zonisamide treatment in adult patient with seizures
大体时间：24 weeks
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24 weeks
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To evaluate seizure freedom over 24 weeks of zonisamide treatment in adult patient with seizures
大体时间：24 weeks
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24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Amitabh Dash、Eisai Pharmaceuticals India Private limited
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2013年5月1日
研究注册日期
首次提交
2011年1月24日
首先提交符合 QC 标准的
2011年1月24日
首次发布 (估计)
2011年1月25日
研究记录更新
最后更新发布 (估计)
2014年1月27日
上次提交的符合 QC 标准的更新
2014年1月23日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.