An observational study in Migraine Disorders, sponsored by Janssen Cilag Pharmaceutica S.A.C.I., Greece. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-27.
Sponsored by Janssen Cilag Pharmaceutica S.A.C.I., Greece · Observational
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 80 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Janssen Cilag Pharmaceutica S.A.C.I., Greece is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Drug: Topiramate
80 patients with diagnosed with migraine
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
Safety of topiramate (number of SAEs, AEs, Laboratory findings)
Time frame: Visits: 1-5
No study locations are listed for this record.
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Janssen Cilag Pharmaceutica S.A.C.I., Greece