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

NCT00297336 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2010-04-27

No results posted yet for this study

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.

Conditions

  • Migraine Disorders

Interventions

DRUG

Topiramate

80 patients with diagnosed with migraine

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2007-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00297336 on ClinicalTrials.gov