Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT05481905
Status:
WITHDRAWN
Last Update Posted:
2023-07-06
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, '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{'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures', 'timeFrame': 'Day 1 to end of the Treatment Period (Day 56) compared to placebo', 'description': 'The median percent change from baseline in 28-day focal seizure frequency (focal aware motor with observable component, focal impaired awareness, or focal to bilateral tonic-clonic seizures) compared to placebo'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures', 'timeFrame': 'Treatment Period (Day 1 to Day 56) compared to placebo', 'description': 'The responder rate defined as the percent of patients who experience a 50% or greater reduction from baseline in seizure frequency in the Treatment Period compared to placebo (designated as primary for the European Medicines Agency)'}, {'measure': 'To evaluate the efficacy of ENX-101', 'timeFrame': 'Treatment Period (Day 29 to Day 56) compared to placebo', 'description': 'The percent of patients who are seizure free during the last 28 days of the Treatment Period'}, {'measure': 'To evaluate the efficacy of ENX-101', 'timeFrame': 'Treatment Period (Day 1 to Day 56) compared to placebo', 'description': 'The percent of patients who are seizure free during the entire Treatment Period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Focal Epilepsy']}, 'descriptionModule': {'briefSummary': 'The ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 18 to 75 years, inclusive, at Screening\n2. Diagnosed with focal (partial onset) epilepsy according to the International League Against Epilepsy (ILAE) 2017 classification of Epilepsy, as confirmed by the Epilepsy Study Consortium\n3. Able to provide an imaging study(ies) \\[magnetic resonance imaging (MRI) scan strongly preferred yet computed tomography (CT) acceptable\\] obtained within the previous 10 years that can rule out a progressive cause of epilepsy\n4. During the 3 months (84 days) immediately prior to Screening:\n\n * ≥ 3 observable focal onset seizures per 28-day period\n * \\<10 seizures per day\n * Any seizure-free interval no more than 21 days in length,\n5. During the 8-week Baseline Period prior to Day 1:\n\n * ≥ 6 observable focal onset seizures\n * \\< 10 seizures per day\n * No seizure-free interval of ≥ 21 days,\n6. Has been treated with antiseizure medications (ASMs) ≥ 2 years and currently being treated with:\n\n * One to 4 ASMs at stable doses for at least 28 days before Screening (not including the rescue medication)\n * Dose adjustments not expected during study\n\nExclusion Criteria:\n\n1. EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave)\n2. Has history of focal onset seizures which involve subjective sensory or psychic phenomena without impairment of consciousness or awareness (formerly referred to as simple partial seizures without observable component) as their only seizure type\n3. Has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut syndrome\n4. Has history of seizures that occur at such a high frequency they cannot be reliably counted (e.g., repetitive, cluster seizures) within the year prior to Screening\n5. Has history of psychogenic non-epileptic seizures\n6. Has history of status epilepticus within two years prior to Screening\n7. Treatment of epilepsy with ASM was initiated \\< 2 years prior to Screening\n8. Ingested excluded concomitant medication within 5 half lives or 28 days (whichever is longer) prior to Screening\n9. Had epilepsy surgery for tissue resection \\< 1 year prior to Screening or radiosurgery \\< 2 years prior to Screening\n10. Had Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS), or other neurostimulation for epilepsy device implanted or activated \\< 1 year prior to Screening, stimulation parameters have been stable for \\< 3 months, or battery life of unit not anticipated to extend for duration of trial\n11. Initiated dietary therapy for epilepsy (e.g., ketogenic diet) \\< 3 months prior to Screening'}, 'identificationModule': {'nctId': 'NCT05481905', 'acronym': 'ENACT', 'briefTitle': 'ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Engrail Therapeutics INC'}, 'officialTitle': 'The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures', 'orgStudyIdInfo': {'id': 'ENX-101-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ENX-101 15mg daily', 'interventionNames': ['Drug: ENX-101']}, {'type': 'EXPERIMENTAL', 'label': 'ENX-101 30mg daily', 'interventionNames': ['Drug: ENX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo daily', 'interventionNames': ['Drug: ENX-101']}], 'interventions': [{'name': 'ENX-101', 'type': 'DRUG', 'description': 'Adjunctive treatment to current antiseizure medication', 'armGroupLabels': ['ENX-101 15mg daily', 'ENX-101 30mg daily', 'Placebo daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Research Institute of Orlando', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33032', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Royal Care Medical Research Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'D&H National Research Centers', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'S&G Research Center Corp.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 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'United States', 'facility': 'Saint Joseph Health System', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Partners Neurology', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Epilepsy and Sleep Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakland University William Beaumont School of 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'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'NeuroScience Research Center, LLC', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '42101', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'DJL Clinical Research', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Mt. 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