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

Novartis India LimitedSandoz House, 5th floorShivsagar EstateDr. Annie Besant RoadIndia1 个研究点分布在 1 个国家目标入组 500 人开始时间: 待定

试验速览

阶段: 4 期
发起方
入组人数: 500
试验地点: 1
主要终点: Seizure Frequency: Reduction is seziure frequency from baseline to end of treatment.

暂无简介。

•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
•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).

•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;
•Any psychiatric coexistent illness that may affect the patient?s compliance with study procedures;
•Patients with other indications than partial seizures, or generalized tonic-clonic seizures;
•Parents or Guardians who are not willing to sign the Informed Consent form.
•Females of child bearing potential who are planning to become pregnant or who are pregnant.

Seizure Frequency: Reduction is seziure frequency from baseline to end of treatment.

时间窗: From baseline to end of study at 24 weeks

Tolerability of the drug: Adverse Events and Serious Adverse Events(From enrollment to end of study at 24 weeks)

发起方

Novartis India LimitedSandoz House, 5th floorShivsagar EstateDr. Annie Besant RoadIndia

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