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

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier:
NCT00297336
First received: February 24, 2006
Last updated: April 26, 2010
Last verified: April 2010
  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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of topiramate (number of SAEs, AEs, Laboratory findings) [ Time Frame: Visits: 1-5 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 22, 2014