Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-07 @ 5:27 PM
Study NCT ID:
NCT05613166
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2022-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Everolimus Treatment of Refractory Epilepsy
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': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-05', 'studyFirstSubmitDate': '2022-11-05', 'studyFirstSubmitQcDate': '2022-11-05', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline frequency of epileptic discharge', 'timeFrame': '1 week', 'description': 'Comparing frequency of epileptic discharge during video-EEG monitoring after versus before treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline seizure frequency', 'timeFrame': '6 months', 'description': 'Comparing number of seizures in 3 months after treatment versus baseline'}, {'measure': 'Change from baseline seizure types', 'timeFrame': '6 months', 'description': 'Comparing types of seizures in 3 months after treatment versus baseline'}, {'measure': 'Change from baseline frequency of seizure-free days', 'timeFrame': '6 months', 'description': 'Comparing seizure-free days in 3 months after treatment versus baseline'}, {'measure': 'Seizure-free rate', 'timeFrame': '3 months', 'description': 'Patients remaining seizure free in 3 months after treatment'}, {'measure': 'Change from baseline occurrence of secondary generalized seizure and status epilepticus', 'timeFrame': '6 months', 'description': 'Comparing number of occurrence of secondary generalized seizure and status epilepticus in 3 months after treatment versus baseline'}, {'measure': 'Quality of life questionnaire (QOLIE-31-Chinese version) scores', 'timeFrame': '3 months', 'description': 'Comparing the scores at 3 months after treatment versus before treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['everolimus'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This project is a prospective, randomized, placebo-controlled, double-blind study that will evaluate the clinical efficacy of everolimus as an adjunctive treatment in adult patients diagnosed with refractory epilepsy.', 'detailedDescription': 'The project consists of a screening and baseline monitoring period of 1-2 weeks, and a treatment period of 1 week, followed by a 3-month follow-up period. Approximately 108 participants will be randomized in a blinded manner to one of three arms in a 1:1:1 fashion (everolimus 1h : everolimus 8-9h : Placebo). After screening, participants will have the first video-EEG monitoring for up to 24 hours to assess baseline levels, followed by 1 week of treatment, the second video-EEG monitoring, and a 3-month post treatment follow-up period. During the treatment period, participants will be given everolimus or placebo directed to seizure events. In the "everolimus 1h" group, everolimus will be administrated immediately after seizure events (within 1 hour); while in the "everolimus 8-9h" group, everolimus administration will be delayed (at 8-9 hours after seizure events). We conduct this study to assess the efficacy of everolimus in adult refractory epilepsy patients under an administration strategy in a limited time window immediately after seizure events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of drug resistant epilepsy, with treatment of at least two approved anti-epileptic drugs (AEDs), and having at least one reported seizure per month during the 3-month baseline phase and no continuous 3-month seizure-free period.\n* Diagnosis of focal epilepsy without secondary generalization.\n* Treatment with a stable dose of AEDs that must have no drug interactions with everolimus (eg, valproic acid, topiramate, oxazepine, phenobarbital, phenytoin, and primidone) for at least 12 weeks before enrollment.\n\nExclusion Criteria:\n\n* History of non-drug treatment for epilepsy, eg, vagus nerve stimulation (VNS), ketogenic diet, and epilepsy surgery.\n* Severe dysfunction in kidney.\n* With significant infectious, immunologic, or oncologic comorbidity at the time of enrollment.\n* Currently taking or previously treated systemically with an mammilian target of rapamycin (mTOR) inhibitor.\n* History of seizures secondary to drug abuse, psychogenic nonepileptic seizures, or an episode of status epilepticus within 1 year before enrollment.'}, 'identificationModule': {'nctId': 'NCT05613166', 'briefTitle': 'Adjunctive Everolimus Treatment of Refractory Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'National Institute on Drug Dependence, China'}, 'officialTitle': 'A Prospective, Randomized, Double-blind, Placebo-Controlled Phase Ⅱ Study to Evaluate the Efficacy of Adjunctive Everolimus Treatment in Patients With Refractory Epilepsy', 'orgStudyIdInfo': {'id': 'PKU-SJ-01-2021-V1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'everolimus 1h', 'description': 'The study participants will orally receive everolimus within 1 hour and placebo at 8-9 hours after each seizure event, but with intervals longer than 24 hours.', 'interventionNames': ['Drug: Everolimus', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'everolimus 8-9h', 'description': 'The study participants will orally receive placebo within 1 hour and everolimus at 8-9 hours after each seizure event, but with intervals longer than 24 hours.', 'interventionNames': ['Drug: Everolimus', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The study participants will orally receive placebo both within 1 hour and at 8-9 hours after each seizure event, but with intervals longer than 24 hours.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Afinitor'], 'description': 'Everolimus will be administrated orally based on seizure events, with an administration interval longer than 24 hours. Participates with a body surface area (BSA) of \\<= 1.2 m\\^2, the dosage was 2.5 mg/time; for BSA 1.3-2.1 m\\^2, the dosage was 5 mg/time; and for BSA \\>=2.2 m\\^2, the dosage was 7.5 mg/time.', 'armGroupLabels': ['everolimus 1h', 'everolimus 8-9h']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vitamin C', 'armGroupLabels': ['everolimus 1h', 'everolimus 8-9h', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weining Ma, MD.', 'role': 'CONTACT', 'email': 'maweining1985@163.com', 'phone': '86-024-96615-36316'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Weining Ma, MD.', 'role': 'CONTACT', 'email': 'maweining1985@163.com', 'phone': '86-024-96615-36316'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Dependence, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}