An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine - Full Text View

Purpose

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.

Condition	Intervention
Migraine Disorders	Drug: Topiramate


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	An Open-label Observational Safety Study During Administration of Topiramate, for the Prophylaxis of Migraine

Resource links provided by NLM:

MedlinePlus related topics: Migraine

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:

Primary Outcome Measures:

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 Outcome Measures:

Safety of topiramate (number of SAEs, AEs, Laboratory findings) [ Time Frame: Visits: 1-5 ]


Enrollment:	80
Study Start Date:	March 2005
Study Completion Date:	February 2007

Groups/Cohorts	Assigned Interventions
001	Drug: Topiramate 80 patients with diagnosed with migraine

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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, they should satisfy the migraine prophylactic medication criteria, and will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297336

Sponsors and Collaborators

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

Investigators


Study Director:	Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial	Janssen-Cilag Pharmaceutica S.A.C.I.

More Information


Responsible Party:	Medical Affairs Director
ClinicalTrials.gov Identifier:	NCT00297336 History of Changes
Other Study ID Numbers:	CR002116
Study First Received:	February 24, 2006
Last Updated:	April 26, 2010

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


Topiramate Migraine Headache Chronic headache Chronic migraine

Additional relevant MeSH terms:


Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Topiramate Anticonvulsants Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 18, 2017