CTRI/2010/091/001239招募中4 期
The prospective, open-label, multicentre, non-comparative, observational post-marketing surveillance study evaluating efficacy and tolerability of TRIoptal® (OXcarbazepine) in children and adolescents with newly diagnosed partial seizures or generalized tonic-clonic seizures as monotherapy in routine clinical practice
ovartis India LimitedSandoz House, 5th floorShivsagar EstateDr. Annie Besant RoadIndia0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
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 children & adolescents between 1 month to 18 years of age (both inclusive) with newly diagnosed epilepsy of the following types:
- •2.Partial seizures (including the seizure subtypes of simple and complex partial seizures, and partial seizures evolving to secondarily generalized seizures)
- •or Generalized tonic clonic seizures
- •3. Patients or their parent/legally-authorized guardian having given written, informed consent and/or assent after the nature of the trial had been fully explained (according to the local legal regulatory requirements)
排除标准
- •1.Age less than 1 month or greater than 18 years;
- •2.Patients with evidence of severe or unstable physical illness or medical condition which would prevent them from participating in the clinical trial;
- •3.Any clinically significant abnormal laboratory findings during screening which remain abnormal upon repeated measurement;
- •4.Known hypersensitivity to Oxcarbazepine or any of the components in the formulation;
- •5. Any psychiatric coexistent illness that may affect the patient?s compliance with study procedures;
- •6. Patients with other indications than partial seizures, or generalized tonic-clonic seizures;
- •7. Parents or Guardians who are not willing to sign the Informed Consent form.
- •8. Females of child bearing potential who are planning to become pregnant or who are pregnant.
研究者
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