NCT00394927

Brief Summary

The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment. Adverse effects and considerations to modify the therapy will be assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy with different seizure types

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Shorter than P25 for all trials

Geographic Reach
7 countries

53 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

November 1, 2006

Last Update Submit

July 18, 2012

Conditions

Keywords

Non-InterventionalSurveillanceAdverse EffectsAntiEpileptic Drug treatment

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed diagnosis of epilepsy requiring anti-epileptic treatment and which are already receiving daily anti-epileptic treatment

You may qualify if:

  • Male and female patients from the age of 4 years
  • Confirmed diagnosis of epilepsy requiring AED treatment
  • Patients already receiving daily AED treatment as a monotherapy or a polytherapy with maximum 2 AEDs within the terms of marketing authorization with the following medications: Carbamazepine, Clobazam, Clonazepam, Gabapentin, Lamotrigine, Levetiracetam, Oxcarbazepine, Phenobarbital, Phenytoin, Pregabalin, Tiagabine, Topiramate, Valproate, Zonisamide
  • Treatment must be stable for at least 3 months prior to assessment
  • Absence of other severe and/or uncontrolled symptomatic chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (53)

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Vienna, Austria

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Blansko, Czechia

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České Budějovice, Czechia

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Hradec Králové, Czechia

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Karlovy Vary, Czechia

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Kopřivnice, Czechia

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Kroměříž, Czechia

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Liberec, Czechia

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Litomyšl, Czechia

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Náchod, Czechia

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Nové Město na Moravě, Czechia

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Prague, Czechia

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Teplice, Czechia

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Třebíč, Czechia

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Ústí nad Labem, Czechia

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Zlín, Czechia

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Aschaffenburg, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bochum, Germany

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Cologne, Germany

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Düsseldorf, Germany

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Ellwangen, Germany

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Göttingen, Germany

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Hirschaid, Germany

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Jena, Germany

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Königsbrück, Germany

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Krefeld, Germany

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Leipzig, Germany

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München, Germany

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Neuberg, Germany

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Oelde, Germany

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Albano Laziale (Roma), Italy

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Napoli, Italy

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Bialystok, Poland

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Elblag, Poland

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Gdansk, Poland

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Katowice, Poland

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Kielce, Poland

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Krakow, Poland

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Lublin, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Botoșani, Romania

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Brasov, Romania

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Bucharest, Romania

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Craiova, Romania

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Galati, Romania

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Iași, Romania

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Lasi, Romania

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Timișoara, Romania

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Sant Boi de Llobregat, Spain

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MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sonja Buyle, M.D.

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

April 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations