CTRI/2010/091/002925已完成4 期
Evaluation of Safety and Efficacy of Zonisamide in Adult Patients with Partial, Generalized and Combined Seizures: An Open Labeled, Non-comparative, Observational StudyAcronym: PMS Zonisamide
Eisai Pharmaceuticals India Private Limited.1st Floor, B-Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri East, Mumbai - 4000720 个研究点目标入组 655 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 655
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects, 18 to 75 years of age inclusive
- •2.Treated or untreated subjects suffering from any of the following types of seizures:
- •a.Partial Seizures: Simple Partial Seizures, Complex Partial Seizures & Secondarily generalized tonic clonic seizures
- •b.Generalized Seizures: Tonic-clonic seizures, tonic seizures & Atypical absence seizures
- •c.Combined seizures (mixed)
- •3.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.
- •4.Female subjects without child bearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible.
- •5.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.
- •6.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.
- •7.Willing to comply with the protocol requirements.
- •8.Able and willing to give the written informed consent.
排除标准
- •1.Subjects with history of non-epileptic seizures (e.g. metabolic, pseudo-seizures).
- •2.Subjects who have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation related seizures.
- •3.Subjects with progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination or tumour).
- •4.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.
- •5.Subjects already receiving zonisamide therapy.
- •6.Subjects who have received an investigational new drug or device in the past three months before screening and enrollment.
- •7.Subjects with known hypersensitivity to zonisamide or sulphonamides.
- •8.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).
- •9.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.
- •10.Subjects currently taking carbonic anhydrase inhibitors (acetazolamide).
- •11.Subjects currently taking Mono-Amine Oxidase Inhibitor?s (MAO-I?s).
- •12.Subjects having a history of pancreatitis, nephrolithiasis or hypercalciuria, clinically significant laboratory abnormalities suggestive of metabolic imbalance.
研究者
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