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临床试验/NCT00297336
NCT00297336已完成不适用

An Open-label Observational Safety Study During Administration of Topiramate, for the Prophylaxis of Migraine

Janssen Cilag Pharmaceutica S.A.C.I., Greece0 个研究点目标入组 80 人开始时间: 2005年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
The primary outcome is effectiveness of topiramate based on the frequency of migraine headaches during the monotherapy with topiramate.

研究概览

简要总结

A 6-month, observational, post authorization safety study for the collection and evaluation of additional safety data on topiramate as a prophylactic treatment for migraines in adult patients. According to current European and international guidelines the safety and efficacy of drugs will be continuously monitored even after their approval and market circulation.The applicable methods of monitoring include: Observational studies, voluntarily reported adverse events, clinical trials of IV phase and Post Authorization Safety Studies ( PASS). Post Authorization Safety Studies (PASS) during the use of a product are a significant source of information regarding the action of the drug or a therapeutic method under the circumstances of every day clinical practice.

详细描述

Previous studies have shown that topiramate is effective in preventing migraine headaches. This is a 6-month observational study to evaluate additional safety data of topiramate in the prevention of migraine in adult patients. The study duration is 6-months, with 5 study visits during the study. Administration of topiramate should be according to current Summary of Product Characteristics (SmPC) and daily clinical practice. The decision to prescribe topiramate is decided by the Health Care Professional and it is independent of the protocol. Based on the investigator's judgement, patients who enter the study should fulfill the criteria for administration of prophylactic treatment. In this study a total number of 80 patients with diagnosed migraine according to the criteria of the International Headache Society HIS (Cephalalgia 1998; 8 (Suppl7) :1-98) will participate. Patients who will be enrolled should be either male or female over 18 years of age, fulfilling the above mentioned criteria and who will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study. Methods of evaluation include tolerability, laboratory tests, vital signs and Body Weight and Body Mass Index (BMI). Efficacy by assessing migraine attacks, symptomatic medications and Headache Impact Test (HIT-6). Observational study - No investigational drug administered.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the IHS (International Headache Society) diagnostic criteria for migraine
  • Patients who satisfy the migraine prophylactic medication criteria

排除标准

  • Ineligible patient according to the marketed Summary of Product Characteristics of topiramate
  • Patient with hypersensitivity to topiramate or to some of its components

研究组 & 干预措施

001

干预措施: Topiramate (Drug)

结局指标

主要结局

The primary outcome is effectiveness of topiramate based on the frequency of migraine headaches during the monotherapy with topiramate.

时间窗: Visit 1 and visit 5

次要结局

  • Safety of topiramate (number of SAEs, AEs, Laboratory findings)(Visits: 1-5)

研究者

发起方
Janssen Cilag Pharmaceutica S.A.C.I., Greece
申办方类型
Industry

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