Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 2:31 AM
Study NCT ID:
NCT06908356
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'C562694', 'term': 'Epilepsy, Idiopathic Generalized'}], '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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs', 'timeFrame': '8 weeks', 'description': 'Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs', 'timeFrame': '8 weeks', 'description': '• Proportion of participants experiencing a ≥50% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for PRAX-628.'}, {'measure': 'To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs', 'timeFrame': '8 weeks', 'description': '• Proportion of participants experiencing seizure freedom, 100% reduction in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628.'}, {'measure': 'To evaluate the efficacy of PRAX 628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs', 'timeFrame': '8 weeks', 'description': '• Number of days after the first administration of PRAX-628 to reach the same or higher number of monthly seizures from the Screening/Observation Period to the Treatment Period'}, {'measure': 'CGI-S Change from Baseline', 'timeFrame': '8 weeks', 'description': "CGI-S assesses the clinician's impression of the participant's current illness state. The clinician should use his/her total clinical experience with this patient population and rate the current severity on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)."}, {'measure': 'PGI-S Change from Baseline', 'timeFrame': '8 weeks', 'description': "PGI-S assesses the participants' impression of their current illness state. The participant is required to assess their condition on a 7-point scale from 1 (Not present) to 7 (extremely severe)."}, {'measure': 'To assess the safety and tolerability of PRAX-628 in adults with FOS or PGTCS currently taking ASMs', 'timeFrame': '8 weeks', 'description': 'The number of participants with Adverse Events (AE) will be reported by preferred term'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Focal Onset Seizure', 'Primary Generalized Epilepsy', 'Tonic-Clonic'], 'conditions': ['Focal Onset Seizure', 'Primary Generalized Epilepsy']}, 'descriptionModule': {'briefSummary': 'An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures', 'detailedDescription': 'An open label clinical trial to evaluate the efficacy and safety of PRAX-628 in adult patients with focal onset or primary generalized tonic-clonic seizures 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\n* A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures.\n* Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy.\n* Participant must have been receiving stable doses of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs).\n* Participant and/or caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening/Observation Period for PGTCS patients.\n\nExclusion Criteria:\n\n* History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening.\n* Planned epilepsy surgery during the course of the clinical trial.\n* History of neurosurgery for seizures \\<1 year prior to enrollment, or radiosurgery \\<2 years prior to enrollment.\n* Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders.\n* Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.\n* Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.\n* History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).\n* Is pregnant or 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.\n* 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.\n* Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.\n* Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening.'}, 'identificationModule': {'nctId': 'NCT06908356', 'briefTitle': 'An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Praxis Precision Medicines'}, 'officialTitle': 'An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures', 'orgStudyIdInfo': {'id': 'PRAX-628-212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label 30mg/day PRAX-628 for 8 weeks', 'description': 'Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks.', 'interventionNames': ['Drug: 30mg PRAX-628']}], 'interventions': [{'name': '30mg PRAX-628', 'type': 'DRUG', 'description': 'Once daily oral', 'armGroupLabels': ['Open-label 30mg/day PRAX-628 for 8 weeks']}]}, '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': '30116', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'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': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10941', 'city': 'Middletown', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'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': '03084', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '03004', 'city': 'Melbourne', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '28010', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Praxis Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], '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'}}}}