An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine

NCT ID: NCT00297336

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2007-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Migraine Disorders

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

001

Topiramate

Intervention Type: DRUG

80 patients with diagnosed with migraine

Interventions

Topiramate

80 patients with diagnosed with migraine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Cilag Pharmaceutica S.A.C.I., Greece

INDUSTRY

Sponsor Role: lead

Principal Investigators

Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Pharmaceutica S.A.C.I.

Other Identifiers

CR002116

Identifier Type: -

Identifier Source: org_study_id