Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06999902
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs', 'timeFrame': '12 weeks', 'description': 'Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs', 'timeFrame': '12 weeks', 'description': 'Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX 628 compared to placebo.'}, {'measure': 'To assess trends over time in efficacy of PRAX 628 on focal seizure frequency', 'timeFrame': '12 weeks', 'description': 'Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo.'}, {'measure': 'To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs', 'timeFrame': '12 weeks', 'description': 'Number of days post-randomization to reach the same number of monthly focal seizures as the Screening/Observation Period through the end of the Treatment Period\n\nProportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628 compared with placebo\n\nImpact of PRAX-628 compared to placebo on PGI-S and CGI-S'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Change in tympanic temperature in Celsius'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Change in heart rate in beats per minute'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Change in blood pressure in mm/Hg'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Change in respiratory rate in breaths per minute'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Incidence of clinically significant ECG abnormalities'}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with focal seizures', 'timeFrame': '12 weeks', 'description': 'Changes in suicidality, as assessed by C-SSRS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Focal Seizure'], 'conditions': ['Focal Seizure']}, 'descriptionModule': {'briefSummary': 'A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)', 'detailedDescription': 'PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.\n2. Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.\n\nExclusion Criteria:\n\n1. Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity.\n2. Planned epilepsy surgery during the course of the clinical trial.\n3. History of neurosurgery for seizures \\<1 year prior to enrollment, or radiosurgery \\<2 years prior to enrollment or vagus nerve stimulation (VNS) implantation.\n4. History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.\n5. History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.\n6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).\n7. Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening.\n8. Is pregnant or is breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose.\n9. Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.'}, 'identificationModule': {'nctId': 'NCT06999902', 'acronym': 'POWER1', 'briefTitle': 'Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Praxis Precision Medicines'}, 'officialTitle': 'A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)', 'orgStudyIdInfo': {'id': 'PRAX-628-321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628', 'description': 'Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of PRAX-628 for 6 weeks followed by 30 mg PRAX 628 for the remaining 6 weeks.', 'interventionNames': ['Drug: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized, Double-Blind Placebo', 'description': 'Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive a matching placebo throughout the 12-week Treatment Period', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks', 'type': 'DRUG', 'description': 'Once daily oral', 'armGroupLabels': ['Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily oral', 'armGroupLabels': ['Randomized, Double-Blind Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '65721', 'city': 'Ozark', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 37.02089, 'lon': -93.20602}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10940', 'city': 'Middletown', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '79912', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '77586', 'city': 'Seabrook', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 29.56412, 'lon': -95.02548}}, {'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18012', 'city': 'Granda', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 43.50128, 'lon': -5.65567}}, {'zip': '28006', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28010', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '08222', 'city': 'Terrassa', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Head of Pharmacovigilance', 'role': 'CONTACT', 'email': 'clinicaltrials@praxismedicines.com', 'phone': '617-300-8460'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Praxis Precision Medicines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Praxis Precision Medicines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}