Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-29 @ 8:16 AM
Study NCT ID:
NCT05236166
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000927', 'term': 'Anticonvulsants'}], 'ancestors': [{'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to seizure relapse', 'timeFrame': '365 days', 'description': 'Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.'}], 'secondaryOutcomes': [{'measure': "Patients' compliance with the assigned withdrawal schedule", 'timeFrame': '365 days', 'description': 'Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.'}, {'measure': 'Severity of relapses and mortality', 'timeFrame': '365 days', 'description': 'Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '19490039', 'type': 'BACKGROUND', 'citation': 'Del Felice A, Beghi E, Boero G, La Neve A, Bogliun G, De Palo A, Specchio LM. Early versus late remission in a cohort of patients with newly diagnosed epilepsy. Epilepsia. 2010 Jan;51(1):37-42. doi: 10.1111/j.1528-1167.2009.02141.x. Epub 2009 Jun 1.'}, {'pmid': '16625621', 'type': 'BACKGROUND', 'citation': 'Ranganathan LN, Ramaratnam S. Rapid versus slow withdrawal of antiepileptic drugs. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005003. doi: 10.1002/14651858.CD005003.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of focal or generalized epilepsy (according to International League Against Epilepsy 1989 criteria)\n* age at epilepsy onset of 16 years or older\n* seizure freedom for at least 2 years\n* treatment with one of the antiepilepsy drugs currently available for monotherapy in Italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide)\n* adherence to the protocol and visit schedules.\n\nExclusion Criteria:\n\n* inability to understand the aims or modalities of the study;\n* current pregnancy or plans to become pregnant during withdrawal period;\n* history of seizure relapse after discontinuation of treatment;\n* history of psychogenic non-epileptic seizures (PNES);\n* history of status epilepticus'}, 'identificationModule': {'nctId': 'NCT05236166', 'acronym': 'RASLOW', 'briefTitle': 'Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy in 2-year Seizure-free Adult Patients With Epilepsy (RASLOW) Study: a Pragmatic Multicentre, Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'GR-2013-02358677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rapid withdrawal', 'description': 'Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).', 'interventionNames': ['Drug: Rapid withdrawal of antiepileptic']}, {'type': 'OTHER', 'label': 'Slow withdrawal', 'description': 'Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).', 'interventionNames': ['Drug: Slow withdrawal of antiepileptic']}], 'interventions': [{'name': 'Rapid withdrawal of antiepileptic', 'type': 'DRUG', 'otherNames': ['antiepileptic'], 'description': 'Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).\n\nDrugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide', 'armGroupLabels': ['Rapid withdrawal']}, {'name': 'Slow withdrawal of antiepileptic', 'type': 'DRUG', 'otherNames': ['antiepileptic'], 'description': 'Slow withdrawal: reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).\n\nDrugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide', 'armGroupLabels': ['Slow withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89100', 'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Magna Graecia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Edoardo Ferlazzo', 'investigatorAffiliation': 'University Magna Graecia'}}}}