An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine
CompletedNCT00297336
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- An Open-label Observational Safety Study During Administration of Topiramate, for the Prophylaxis of Migraine
- Conditions
- Interventions
- Sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
- Start date
- 2005-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00297336