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An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine
This study has been completed.
Sponsored by: Janssen Cilag Pharmaceutica S.A.C.I., Greece
Information provided by: Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier: NCT00297336
  Purpose

A 6-month, observational, post authorization safety study for the collection and evaluation of safety data on topiramate as a prophylactic treatment for migraines in adult patients.


Condition Intervention Phase
Migraine
Drug: topiramate
Phase IV

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Topiramate
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: An Open-Label Observational Safety Study During Administration of Topamac, for the Prophylaxis of Migraine

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

Estimated Enrollment: 80
Study Start Date: March 2005
Study Completion Date: February 2007
Detailed Description:

Previous studies have shown that topiramate is effective in preventing migraine headaches. This is a 6-month observational study to evaluate the safety of topiramate in the prevention of migraine in adult patients. The study duration is 6-months, with 5 study visits during the study. The dosage of topiramate should then be increased at 1-week intervals by increments of 25 mg daily. If the patient is unable to tolerate the individualized regimen, longer intervals between doses increments may be used. The recommended total daily dose of topiramate treatment for the prevention of migraine is 100mg daily administered in two divided doses. Some patients may benefit from the total daily dose of 50mg daily. There are patients who received a total daily dose of up to 200mg daily. Dose and individualization rate should be determined by the clinical outcome. The primary objective of this study is the collection and evaluation of data on the safety of topiramate in the prevention of migraine in adult patients over 6 months.

Topiramate will be administered according to the physician's prescription; dose and individualization rate (rate at which the dose of topiramate would be increased) will be determined by the clinical outcome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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., Greece
  More Information

Study ID Numbers: CR002116
Study First Received: February 24, 2006
Last Updated: March 19, 2008
ClinicalTrials.gov Identifier: NCT00297336  
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:
chronic headache
Topiramate
headache
migraine
chronic migraine

Study placed in the following topic categories:
Migraine Disorders
Headache
Topiramate
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:
Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009