Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-02-28 @ 10:51 PM
Study NCT ID:
NCT03636958
Status:
WITHDRAWN
Last Update Posted:
2022-06-27
First Post:
2018-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'concomitant decision of the sponsor and the PI, lack of patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of crisis at baseline', 'timeFrame': '6 weeks', 'description': 'The monthly frequency of crisis'}, {'measure': 'Numbers of crisis under treatment', 'timeFrame': '5 weeks', 'description': 'The monthly frequency of crisis during treatment period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Epilepsy']}, 'descriptionModule': {'briefSummary': "Gliomas are primitive brain tumors frequently associated with epilepsy. In a significant number of these patients epilepsy is resistant to antiepileptic drugs. There are currently no recommendations for the management of these drug-resistant epilepsies associated with glioma. In addition, few studies have addressed the subject and no treatment appears to be superior to others in the literature for this indication. In addition, many antiepileptic drugs pose problems of tolerance or interaction with chemotherapy in these patients.\n\nFundamental studies on glioma-associated epilepsies have shown that there is a major dysregulation of glutamatergic systems involved in epileptogenesis and tumor growth. Targeting this glutamatergic system seems particularly interesting from a physiopathological point of view. Perampanel is a recent antiepileptic treatment with a novel mode of action targeting AMPA glutamate receptors. It has been shown to be effective in patients with drug-resistant epilepsies. He has demonstrated his tolerance in these patients. He has obtained a marketing authorization and is therefore used in routine epileptology without serious problems of tolerance being reported. It is neither an inducer nor an enzyme inhibitor, avoiding the problems of interaction with chemotherapy and is used in a daily dose facilitating compliance.\n\nTherefore, there may be specific antiepileptic efficacy of perampanel in patients with glioma. Nevertheless, the only current data is limited to a retrospective study of 12 patients.\n\nThe objective of this protocol is to evaluate the efficacy and safety of perampanel in patients with glioma with drug-resistant epilepsy.\n\na prospective randomized study with two parallel arms: antiepileptic combination therapy with perampanel and antiepileptic combination therapy without perampanel (free choice of the practitioner). The main criterion of judgment will be the decrease of the monthly frequency of crisis. Secondary endpoints will assess tolerance, efficacy on responder rate (at least 50% decrease in seizure frequency), seizure severity (secondary generalization, loss of consciousness), and quality. patients' lives (quality of life questionnaires, side effects and anxiety / depression). The duration of participation per patient will be 23 weeks (6 weeks of baseline, 5 weeks of titration and 12 weeks of maintenance). The recruitment period will be 3 years. Investigators plan to recruit 120 patients.\n\nIn the context of no recommendation in the management of these patients, superior efficacy of perampanel compared with other antiepileptic drugs is expected. This would allow targeted treatment in this population and confirm the tolerance of this treatment in these patients.", 'detailedDescription': "Background: Gliomas are primitive brain tumors frequently associated with epilepsy. In a significant number of these patients epilepsy is resistant to antiepileptic drugs. There are currently no recommendations for the management of these drug-resistant epilepsies associated with glioma. In addition, few studies have addressed the subject and no treatment appears to be superior to others in the literature for this indication. In addition, many antiepileptic drugs pose problems of tolerance or interaction with chemotherapy in these patients.\n\nRational: Fundamental studies on glioma-associated epilepsies have shown that there is a major dysregulation of glutamatergic systems involved in epileptogenesis (= perpetuation of epileptic seizures) and tumor growth (Huberfeld and Vecht, 2016). Targeting this glutamatergic system seems particularly interesting from a physiopathological point of view. Perampanel is a recent antiepileptic treatment with a novel mode of action targeting AMPA glutamate receptors. It has been shown to be effective in patients with drug-resistant epilepsies. He has demonstrated his tolerance in these patients. He has obtained a marketing authorization and is therefore used in routine epileptology without serious problems of tolerance being reported. It is neither an inducer nor an enzyme inhibitor, avoiding the problems of interaction with chemotherapy and is used in a daily dose facilitating compliance.\n\nTherefore, there may be specific antiepileptic efficacy of perampanel in patients with glioma. Nevertheless, the only current data is limited to a retrospective study of 12 patients.\n\nThe objective of this protocol is to evaluate the efficacy and safety of perampanel in patients with glioma with drug-resistant epilepsy.\n\nThe investigators want to perform a prospective randomized study with two parallel arms: antiepileptic combination therapy with perampanel and antiepileptic combination therapy without perampanel (free choice of the practitioner). The main criterion of judgment will be the decrease of the monthly frequency of crisis. Secondary endpoints will assess tolerance, efficacy on responder rate (at least 50% decrease in seizure frequency), seizure severity (secondary generalization, loss of consciousness), and quality. patients' lives (quality of life questionnaires, side effects and anxiety / depression). The duration of participation per patient will be 23 weeks (6 weeks of baseline, 5 weeks of titration and 12 weeks of maintenance). The recruitment period will be 3 years. The investigators plan to recruit 120 patients.\n\nExpected benefits: In the context of no recommendation in the management of these patients, the investigators hope to demonstrate superior efficacy of perampanel compared with other antiepileptic drugs. This would allow targeted treatment in this population and confirm the tolerance of this treatment in these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient, male or female, over 18 years old\n\n* Glioma confirmed by histology\n* Not in progression (clinico-radiological criterion RANO, (Wen et al., 2014), see appendix 1)\n\n * No clinical worsening (excluding epileptic seizures)\n * No increase greater than 25% in contrast enhancement after gadolinium injection\n * No increase in the T2 / FLAIR hyper signal\n * Absence of new lesion\n* Diagnosis of drug-resistant epilepsy according to international epilepsy definitions (Fisher 2014 and Kwan 2010, see Appendices 2 and 3)\n\n o Repeated epileptic seizures despite testing of two effective dose antiepileptic drugs tried at least 3 months\n* With at least 2 attacks per month (to ensure visibility on the duration of the study of the antiepileptic effect, see below)\n* Patient with epileptic seizures not limited to only subjective signs\n\nExclusion Criteria:\n\n* Pregnant or lactating woman\n* Minor\n* Impossibility of signing consent\n* No affiliation to a social security scheme (beneficiary or beneficiary)\n* Person in emergency,\n* Person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his or her consent\n* Patient with at least 2 generalized tonic-clonic seizures per month.'}, 'identificationModule': {'nctId': 'NCT03636958', 'briefTitle': 'Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Study of the Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy', 'orgStudyIdInfo': {'id': '2018-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'they will receive conventional antiepileptic treatment (antiepileptic combination therapy) without perampanel', 'interventionNames': ['Drug: conventional antiepileptic treatment']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'they will receive conventional antiepileptic treatment (antiepileptic combination therapy) with perampanel', 'interventionNames': ['Drug: Perampanel', 'Drug: conventional antiepileptic treatment']}], 'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'description': 'Perampanel is an antiepileptic with a novel mechanism of action as it targets post-synaptic AMPA receptors. It has been shown to be effective as adjunctive therapy (dual therapy) for partial / focal epilepsy seizures and generalized in patients over 12 years of age.', 'armGroupLabels': ['experimental group']}, {'name': 'conventional antiepileptic treatment', 'type': 'DRUG', 'description': 'choice of the molecule is left to the discretion of the clinician excluding the following benzodiazepines: clobazam, clonazepam, diazepam. Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin, topiramate, phenytoin, phenobarbital, zonisamide, vigabatrin.', 'armGroupLabels': ['control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'state': 'PACA', 'country': 'France', 'facility': 'Assistance Publique Des Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'EMILIE GARRIDO PRADALIE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}