An Open Observational Safety Study During Administration of Topamac, as Monotherapy in Epileptic Patients With no Prior Treatment or Unsuccessfully Treated With Other Antiepileptic Drug
Sponsor study identifier
observational
80
0 countries
N/A
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
February 2007
Actual (reported)The purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previous antiepileptic medication.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
February 24, 2006
Actual (reported)February 28, 2006
Actual (reported)February 2007
Actual (reported)The primary outcome is efficacy.
Visit 1-5
Tolerability
Visit: 1-5
Safety of topiramate monotherapy
Visit: 1-5
75 patients over the age of 2 years old with epilepsy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
In this study a total number of 75 patients will be enrolled. Adults and children over 2 years of age who are eligible according to the approved SmPC of topiramate and their seizures are not manageable. Patients with new exposure to an AE treatment for epilepsy or lack of response to the previous treatment. Patients 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 or a relative or a legal authorised representative.
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial
Janssen-Cilag Pharmaceutica S.A.C.I.
80 participants (actual enrollment reported by the registry).
First Submitted
February 24, 2006
First Posted
February 28, 2006
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
Contact the study team to confirm eligibility.
Study Completion
February 2007
Actual (reported)Last Updated
April 27, 2010
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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