Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-30 @ 3:21 AM
Study NCT ID:
NCT01830868
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078305', 'term': 'Zonisamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2013-04-10', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention Rate of Zonisamide (ZNS) after 6 months from Baseline', 'timeFrame': 'Up to 6 months', 'description': 'The retention rate or the proportion of patients still receiving ZNS after 6 months will be assessed. At each of the two visits after 3 months and 6 months (final assessment or early discontinuation), the clinician will record whether the patient is still on ZNS treatment, or whether treatment has been discontinued.'}], 'secondaryOutcomes': [{'measure': 'Change in Seizure Frequency after 3 and 6 months from Baseline', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': 'Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ZNS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ZNS', 'AED', 'Partial Onset Seizures', 'Retention Rate', 'Seizure Control', 'Antiepileptic', 'Secondary generalization', 'Seizure freedom rates'], 'conditions': ['Partial Onset Seizures']}, 'descriptionModule': {'briefSummary': 'This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.', 'detailedDescription': 'Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Patients With Partial Onset Seizures', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The decision to prescribe ZNS was made by the physician before and independently of his/her decision to include the patient in the study\n* Patients treated with one drug licensed for the use as monotherapy in partial onset seizures\n* Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS\n* Patient was prescribed ZNS no longer than 2 weeks before baseline\n* Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)\n* Aged 18 years or older\n* Capable of understanding the purpose of the study, fully informed and having given written informed consent.\n\nExclusion Criteria:\n\n* Patients that have started ZNS outside the approved SmPC at enrolment\n* Simultaneous participation in an interventional clinical trial and/or taking an investigational drug\n* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient."}, 'identificationModule': {'nctId': 'NCT01830868', 'briefTitle': 'A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Observational Study of the Use of Zonisamide (ZNS) in the Adjunctive Treatment of Adult Patients With Partial Onset Seizures Treated With One Antiepileptic Drug (AED) as Baseline Medication', 'orgStudyIdInfo': {'id': 'E2090-E044-410'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Zonisamide tablets', 'interventionNames': ['Drug: Zonisamide tablets']}], 'interventions': [{'name': 'Zonisamide tablets', 'type': 'DRUG', 'otherNames': ['ZNS'], 'description': 'The recommended initial daily dose is 50 mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg. Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4 (cytochrome P450)-inducing agents, may respond to lower doses.', 'armGroupLabels': ['Zonisamide tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ried', 'country': 'Austria', 'geoPoint': {'lat': 47.99722, 'lon': 12.96639}}, {'city': 'Hillerød', 'country': 'Denmark', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'city': 'Asperg', 'country': 'Germany', 'geoPoint': {'lat': 48.90525, 'lon': 9.13502}}, {'city': 'Baesweiler', 'country': 'Germany', 'geoPoint': {'lat': 50.90964, 'lon': 6.18874}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bielefeld', 'country': 'Germany', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Dortmund', 'country': 'Germany', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Eisenach', 'country': 'Germany', 'geoPoint': {'lat': 50.9807, 'lon': 10.31522}}, {'city': 'Erbach im Odenwald', 'country': 'Germany', 'geoPoint': {'lat': 49.66148, 'lon': 8.99402}}, {'city': 'Erlangen', 'country': 'Germany', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Fürth', 'country': 'Germany', 'geoPoint': {'lat': 49.47593, 'lon': 10.98856}}, {'city': 'Gladenbach', 'country': 'Germany', 'geoPoint': {'lat': 50.76847, 'lon': 8.58085}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Haßfurt', 'country': 'Germany', 'geoPoint': {'lat': 50.03521, 'lon': 10.5156}}, {'city': 'Jülich', 'country': 'Germany', 'geoPoint': {'lat': 50.92149, 'lon': 6.36267}}, {'city': 'Kastellaun', 'country': 'Germany', 'geoPoint': {'lat': 50.06922, 'lon': 7.44154}}, {'city': 'Lage', 'country': 'Germany', 'geoPoint': {'lat': 51.99223, 'lon': 8.79301}}, {'city': 'Lappersdorf', 'country': 'Germany', 'geoPoint': {'lat': 49.04694, 'lon': 12.0913}}, {'city': 'Lauf', 'country': 'Germany', 'geoPoint': {'lat': 48.65, 'lon': 8.13333}}, {'city': 'Lohr a. Main', 'country': 'Germany', 'geoPoint': {'lat': 49.98922, 'lon': 9.57223}}, {'city': 'Malchin', 'country': 'Germany', 'geoPoint': {'lat': 53.73836, 'lon': 12.76875}}, {'city': 'Mönchengladbach', 'country': 'Germany', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Neuburg an der Donau', 'country': 'Germany', 'geoPoint': {'lat': 48.73218, 'lon': 11.18709}}, {'city': 'Neusaß', 'country': 'Germany', 'geoPoint': {'lat': 49.62198, 'lon': 9.34827}}, {'city': 'Osnabrück', 'country': 'Germany', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Remscheid', 'country': 'Germany', 'geoPoint': {'lat': 51.17983, 'lon': 7.1925}}, {'city': 'Saarbrücken', 'country': 'Germany', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'city': 'Schorndorf', 'country': 'Germany', 'geoPoint': {'lat': 48.80537, 'lon': 9.52721}}, {'city': 'Schwäbisch Gmünd', 'country': 'Germany', 'geoPoint': {'lat': 48.79947, 'lon': 9.79809}}, {'city': 'Senftenberg', 'country': 'Germany', 'geoPoint': {'lat': 51.52517, 'lon': 14.00164}}, {'city': 'Stralsund', 'country': 'Germany', 'geoPoint': {'lat': 54.30911, 'lon': 13.0818}}, {'city': 'Stuttgart', 'country': 'Germany', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Velen', 'country': 'Germany', 'geoPoint': {'lat': 51.89447, 'lon': 6.98807}}, {'city': 'Drammen', 'country': 'Norway', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Hajo Hamer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}