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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece
• Treatments: Topiramate

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