NCT00394927

Completed

Adverse Event Scale in Patients With Epilepsy (aEscape) - A ...

UCB Pharma Source

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Other study identifiers

Sponsor study identifier

N01228

Study Type

observational

Estimated enrollment

1,000

Locations

7 countries

Sites

53

Timeline

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2007

Actual (reported)

Study Completion

August 2007

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 1,000 participants
Study completion date: August 2007
Actual (reported)
Listed locations: 7 countries · 53 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 1, 2006
Actual (reported)
First Posted
November 2, 2006
Actual (reported)
Study Start
April 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2007
Actual (reported)
Study Completion
August 2007
Actual (reported)

Last Updated: July 19, 2012
Status Verified: July 2012
Last Update Submitted: July 18, 2012

Conditions

Epilepsy

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

Sponsors & Collaborators

International Bureau for Epilepsy
Othercollaborator
UCB Pharma
Industrylead

Study Sites (53)

Vienna, Austria

Blansko, Czechia

České Budějovice, Czechia

Hradec Králové, Czechia

Karlovy Vary, Czechia

Kopřivnice, Czechia

Kroměříž, Czechia

Liberec, Czechia

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 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2007

Actual (reported)

NCT00175903

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Phase 3Completed

NCT00761774

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

Phase 3Completed

NCT00291655

Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

Phase 3Completed

NCT00175864

Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

Phase 3Withdrawn

NCT00698581

A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Phase 3Terminated

NCT00319605

Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam

Completed

Absence of other severe and/or uncontrolled symptomatic chronic illness

Contact the study team to confirm eligibility.

Litomyšl, Czechia

Náchod, Czechia

Nové Město na Moravě, Czechia

Prague, Czechia

Teplice, Czechia

Třebíč, Czechia

Ústí nad Labem, Czechia

Zlín, Czechia

Aschaffenburg, Germany

Berlin, Germany

Bielefeld, Germany

Bochum, Germany

Cologne, Germany

Düsseldorf, Germany

Ellwangen, Germany

Göttingen, Germany

Hirschaid, Germany

Jena, Germany

Königsbrück, Germany

Krefeld, Germany

Leipzig, Germany

München, Germany

Neuberg, Germany

Oelde, Germany

Albano Laziale (Roma), Italy

Naples, Italy

Bialystok, Poland

Elblag, Poland

Gdansk, Poland

Katowice, Poland

Kielce, Poland

Krakow, Poland

Lublin, Poland

Poznan, Poland

Warsaw, Poland

Wroclaw, Poland

Botoșani, Romania

Brasov, Romania

Bucharest, Romania

Craiova, Romania

Galati, Romania

Iași, Romania

Lasi, Romania

Timișoara, Romania

Sant Boi de Llobregat, Spain

Study Completion

August 2007

Actual (reported)

Last Updated

July 19, 2012

Record last verified: 2012-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00394927
Data provider: ClinicalTrials.gov
Source updated: 2012-07-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:28 UTC

Locations

AT(1)CZ(15)DE(16)ES(1)IT(2)PL(10)RO(8)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (53)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations