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

NCT00297336 | Completed

• 1 other identifier: CR002116
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine Disorders

Keywords

Topiramate; Migraine; Headache; Chronic headache; Chronic migraine

Outcome Measures

Primary Outcomes (1)

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

  Visit 1 and visit 5

Secondary Outcomes (1)

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

  Visits: 1-5

Study Arms (1)

001

Drug: Topiramate

Interventions

Topiramate DRUG

80 patients with diagnosed with migraine

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who meet the IHS (International Headache Society) diagnostic criteria for migraine
• Patients who satisfy the migraine prophylactic medication criteria

You may not qualify if:

• Ineligible patient according to the marketed Summary of Product Characteristics of topiramate
• Patient with hypersensitivity to topiramate or to some of its components

Sponsors & Collaborators

• Janssen Cilag Pharmaceutica S.A.C.I., Greece: lead

MeSH Terms

Conditions

Migraine Disorders; Headache; Headache Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial

  Janssen-Cilag Pharmaceutica S.A.C.I.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: March 1, 2005
• Study Completion: February 1, 2007
• Last Updated: April 27, 2010

Record last verified: 2010-04