EpilepsyNCT00394927
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients
An observational study of Epilepsy, run by UCB Pharma at 53 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 1,000 participants
- Where
- 53 sitesin 7 countries
- Study dates
- Apr 2007to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed diagnosis of epilepsy requiring anti-epileptic treatment and which are already receiving daily anti-epileptic treatment
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
Germany16 sites
Study site
Aschaffenburg
Study site
Berlin
Study site
Bielefeld
Study site
Bochum
Study site
Cologne
Study site
Düsseldorf
Study site
Ellwangen
Study site
Göttingen
Study site
Hirschaid
Study site
Jena
Study site
Königsbrück
Study site
Krefeld
Study site
Leipzig
Study site
München
Study site
Neuberg
Study site
Oelde
Czechia15 sites
Study site
Blansko
Study site
České Budějovice
Study site
Hradec Králové
Study site
Karlovy Vary
Study site
Kopřivnice
Study site
Kroměříž
Study site
Liberec
Study site
Litomyšl
Study site
Náchod
Study site
Nové Město na Moravě
Study site
Prague
Study site
Teplice
Study site
Třebíč
Study site
Ústí nad Labem
Study site
Zlín
Poland10 sites
Study site
Bialystok
Study site
Elblag
Study site
Gdansk
Study site
Katowice
Study site
Kielce
Study site
Krakow
Study site
Lublin
Study site
Poznan
Study site
Warsaw
Study site
Wroclaw
Romania8 sites
Study site
Botoșani
Study site
Brasov
Study site
Bucharest
Study site
Craiova
Study site
Galati
Study site
Iași
Study site
Lasi
Study site
Timișoara
About this study
Official title: A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy
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
- Conditions
- Epilepsy
- Keywords
- Non-Interventional, Surveillance, Adverse Effects, AntiEpileptic Drug treatment
- Medical subject headings
- Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Bureau for Epilepsy
- Investigators
- Sonja Buyle, M.D., Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394927
- Sponsor's protocol ID
- N01228
- Status last verified
- Jul 2012
- First submitted
- 1 Nov 2006
- Last updated
- 19 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT00394927
- Acronym / sponsor ID
- N01228
- Conditions
- Epilepsy
- Keywords
- Non-Interventional, Surveillance, Adverse Effects, AntiEpileptic Drug treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Collaborators
- International Bureau for Epilepsy
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed diagnosis of epilepsy requiring anti-epileptic treatment and which are already receiving daily anti-epileptic treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Buyle, M.D. study director
UCB Pharma
53 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by UCB Pharma at 53 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Germany, Czechia, Poland, Romania, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.