An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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.