Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00394927
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2006-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2006-11-01', 'studyFirstSubmitQcDate': '2006-11-01', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Non-Interventional', 'Surveillance', 'Adverse Effects', 'AntiEpileptic Drug treatment'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confirmed diagnosis of epilepsy requiring anti-epileptic treatment and which are already receiving daily anti-epileptic treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients from the age of 4 years\n* Confirmed diagnosis of epilepsy requiring AED treatment\n* 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\n* Treatment must be stable for at least 3 months prior to assessment\n* Absence of other severe and/or uncontrolled symptomatic chronic illness'}, 'identificationModule': {'nctId': 'NCT00394927', 'briefTitle': 'Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy', 'orgStudyIdInfo': {'id': 'N01228'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Blansko', 'country': 'Czechia', 'geoPoint': {'lat': 49.36304, 'lon': 16.64446}}, {'city': 'České Budějovice', 'country': 'Czechia', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Karlovy Vary', 'country': 'Czechia', 'geoPoint': {'lat': 50.23271, 'lon': 12.87117}}, {'city': 'Kopřivnice', 'country': 'Czechia', 'geoPoint': {'lat': 49.59947, 'lon': 18.1448}}, {'city': 'Kroměříž', 'country': 'Czechia', 'geoPoint': {'lat': 49.29785, 'lon': 17.39312}}, {'city': 'Liberec', 'country': 'Czechia', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'city': 'Litomyšl', 'country': 'Czechia', 'geoPoint': {'lat': 49.86809, 'lon': 16.31298}}, {'city': 'Náchod', 'country': 'Czechia', 'geoPoint': {'lat': 50.4167, 'lon': 16.16289}}, {'city': 'Nové Město na Moravě', 'country': 'Czechia', 'geoPoint': {'lat': 49.56144, 'lon': 16.07418}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Teplice', 'country': 'Czechia', 'geoPoint': {'lat': 50.6404, 'lon': 13.82451}}, {'city': 'Třebíč', 'country': 'Czechia', 'geoPoint': {'lat': 49.21492, 'lon': 15.88166}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Zlín', 'country': 'Czechia', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'city': 'Aschaffenburg', 'country': 'Germany', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bielefeld', 'country': 'Germany', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Bochum', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Ellwangen', 'country': 'Germany', 'geoPoint': {'lat': 48.96164, 'lon': 10.13173}}, {'city': 'Göttingen', 'country': 'Germany', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hirschaid', 'country': 'Germany', 'geoPoint': {'lat': 49.81789, 'lon': 10.98918}}, {'city': 'Jena', 'country': 'Germany', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Königsbrück', 'country': 'Germany', 'geoPoint': {'lat': 51.26451, 'lon': 13.9054}}, {'city': 'Krefeld', 'country': 'Germany', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'city': 'Leipzig', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Neuberg', 'country': 'Germany', 'geoPoint': {'lat': 50.48895, 'lon': 12.39485}}, {'city': 'Oelde', 'country': 'Germany', 'geoPoint': {'lat': 51.8289, 'lon': 8.14724}}, {'city': 'Albano Laziale (Roma)', 'country': 'Italy', 'geoPoint': {'lat': 41.72748, 'lon': 12.659}}, {'city': 'Napoli', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Elblag', 'country': 'Poland', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Kielce', 'country': 'Poland', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Botoșani', 'country': 'Romania', 'geoPoint': {'lat': 47.75, 'lon': 26.66667}}, {'city': 'Brasov', 'country': 'Romania', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Craiova', 'country': 'Romania', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Galati', 'country': 'Romania', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Lasi', 'country': 'Romania'}, {'city': 'Timișoara', 'country': 'Romania', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Sant Boi de Llobregat', 'country': 'Spain', 'geoPoint': {'lat': 41.34357, 'lon': 2.03659}}], 'overallOfficials': [{'name': 'Sonja Buyle, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'International Bureau for Epilepsy', 'class': 'OTHER'}]}}}