Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-28 @ 1:53 PM
Study NCT ID:
NCT05201703
Status:
TERMINATED
Last Update Posted:
2024-07-31
First Post:
2022-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fycompa in Catamenial Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katherine.zarroli@jax.ufl.edu', 'phone': '3025615456', 'title': 'Dr. Katherine Zarroli', 'organization': 'University of Florida - Jacksonville'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 months per participant assessment (2 months of baseline and 2 months of treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'Fycompa 4 mg Daily', 'description': 'Fycompa: Fycompa 4 mg daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fycompa 4 mg Daily With a Boost to 6 mg Daily', 'description': 'Fycompa with a boost: Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling off', 'notes': 'Patient just felt "off" and not like herself on medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fycompa 4 mg Daily', 'description': 'Fycompa: Fycompa 4 mg daily'}, {'id': 'OG001', 'title': 'Fycompa 4 mg Daily With a Boost to 6 mg Daily', 'description': 'Fycompa with a boost: Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (2 months) and treatment (2 months)', 'description': 'To measure the 50% responder rate will be analyzed using Chi square analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistics unable to be performed due to low sample size.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fycompa 4 mg Daily', 'description': 'Fycompa: Fycompa 4 mg daily'}, {'id': 'FG001', 'title': 'Fycompa 4 mg Daily With a Boost to 6 mg Daily', 'description': 'Fycompa with a boost: Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Did not understand how to boost medication despite counseling; did not boost', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject did not tolerate the treatment (perampanel) due to mild side effects so exited the study.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '* 1 subject was excluded from the study due to a positive C-SSRS.\n* 2 subjects were excluded during the baseline period (1 subject did not have her menstrual period during the baseline period so dropped out due to irregular menses and 1 subject did not have any seizures during the baseline phase).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fycompa 4 mg Daily', 'description': 'Fycompa: Fycompa 4 mg daily'}, {'id': 'BG001', 'title': 'Fycompa 4 mg Daily With a Boost to 6 mg Daily', 'description': 'Fycompa with a boost: Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '40'}, {'value': '31.7', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '39'}, {'value': '33.6', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-17', 'size': 950595, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-14T11:57', 'hasProtocol': True}, {'date': '2022-03-17', 'size': 28650, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-29T13:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-01-07', 'resultsFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-30', 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies', 'timeFrame': 'Baseline (2 months) and treatment (2 months)', 'description': 'To measure the 50% responder rate will be analyzed using Chi square analysis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catamenial Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed investigation is to carry out a pilot study of add-on perampanel (Fycompa) in women with perimenstural (C1) catamenial epilepsy. Perampanel, a noncompetitive AMPA receptor antagonist, is uniquely positioned to decrease progesterone receptor mediated excitotoxicity. This mechanism of action would allow a novel use of perampanel as an effective treatment of C1 catamenial epilepsy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Study is enrolling women of child bearing potential to investigate the use of perampanel in women with perimenstrual catamenial epilepsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history\n* Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses\n* ≥18-50 years old\n* ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED)\n* Seizures must show a C1 catamenial pattern in 2 of 3 documented cycles i. C1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. The menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (Herzog et al, 1997). Of note, in the NIH Progesterone Trial, the level of catameniality was 1.69 based on Herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation.\n* Willingness and ability to comply with scheduled visits and study procedures\n\nExclusion Criteria:\n\n* Progressive neurologic or systemic disorder\n* Use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing IUD who still have monthly periods may be enrolled)\n\n a. Women on system hormonal contraception will be excluded as these women are not ovulatory\n* Subject is pregnant or breastfeeding\n* Active suicidal or homicidal ideation\n* Comatose individuals.'}, 'identificationModule': {'nctId': 'NCT05201703', 'briefTitle': 'Fycompa in Catamenial Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy', 'orgStudyIdInfo': {'id': 'IRB202102694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fycompa 4 mg daily', 'interventionNames': ['Drug: Fycompa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fycompa 4 mg daily with a boost to 6 mg daily', 'interventionNames': ['Drug: Fycompa with a boost']}], 'interventions': [{'name': 'Fycompa', 'type': 'DRUG', 'otherNames': ['Perampanel'], 'description': 'Fycompa 4 mg daily', 'armGroupLabels': ['Fycompa 4 mg daily']}, {'name': 'Fycompa with a boost', 'type': 'DRUG', 'otherNames': ['Perampanel'], 'description': 'Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.', 'armGroupLabels': ['Fycompa 4 mg daily with a boost to 6 mg daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Katherine Zarroli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eisai Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}