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

Information source: Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Disorders

Intervention: Topiramate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Official(s) and/or principal investigator(s):
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study Director, Affiliation: Janssen-Cilag Pharmaceutica S.A.C.I.


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.

Clinical Details

Official title: An Open-label Observational Safety Study During Administration of Topiramate, for the Prophylaxis of Migraine

Study design: Time Perspective: Prospective

Primary outcome: The primary outcome is effectiveness of topiramate based on the frequency of migraine headaches during the monotherapy with topiramate.

Secondary outcome: Safety of topiramate (number of SAEs, AEs, Laboratory findings)

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients who meet the IHS (International Headache Society) diagnostic criteria for


- Patients who satisfy the migraine prophylactic medication criteria

Exclusion Criteria:

- Ineligible patient according to the marketed Summary of Product Characteristics of


- Patient with hypersensitivity to topiramate or to some of its components

Locations and Contacts

Additional Information

Starting date: March 2005
Last updated: April 26, 2010

Page last updated: August 23, 2015

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