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

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

80 patients with diagnosed with migraine

Primary outcomes

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

Time frame: Visit 1 and visit 5

Secondary outcomes

Safety of topiramate (number of SAEs, AEs, Laboratory findings)

Time frame: Visits: 1-5

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2007
First posted: Feb 28, 2006
Registry last updated: Apr 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed