Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 4:37 PM
Study NCT ID:
NCT06990867
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Reperfusion to Improve Outcomes and Neurologic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 740}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days', 'timeFrame': '90 days'}, {'measure': 'Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization', 'timeFrame': 'Within 36 hours post-randomization'}], 'secondaryOutcomes': [{'measure': 'Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days', 'timeFrame': '90 days'}, {'measure': 'Proportion of participants with functional independence at 90 days', 'timeFrame': '90 days', 'description': 'Functional independence: mRS score 0-2'}, {'measure': 'Incidence of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': '90 days'}, {'measure': 'Incidence of major bleeding within 24 hours and 14 days of study treatment', 'timeFrame': 'Within 24 hours and 14 days of study treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reperfusion', 'ORION', 'Acute Ischemic Stroke', 'Late Presentation', 'JX10', 'thrombolytic'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours.\n\nThe main question the study aims to answer are:\n\n1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS.\n2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS.\n\nDuring Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 90 years old.\n2. Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA).\n3. Radiographic evidence of salvageable tissue.\n4. Pre-treatment score of NIHSS ≥ 5.\n\nExclusion Criteria:\n\n1. Radiographic findings pre-randomization of any of the following:\n\n 1. Large core infarction, or\n 2. Occlusion in more than 1 vascular territory, or\n 3. Significant mass effect or clinically significant cerebral edema, or\n 4. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or\n 5. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.\n2. Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.\n3. Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.\n4. Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count \\< 100,000/μL, international normalized ratio \\> 1.7, aPTT \\> 40 seconds, or prothrombin time \\> 15 seconds.\n5. Major trauma, surgery, or invasive procedures.\n6. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.\n7. Pre-treatment blood glucose \\> 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose \\< 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement."}, 'identificationModule': {'nctId': 'NCT06990867', 'acronym': 'ORION', 'briefTitle': 'Optimizing Reperfusion to Improve Outcomes and Neurologic Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corxel Pharmaceuticals'}, 'officialTitle': 'Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke With Late Presentations', 'orgStudyIdInfo': {'id': 'JX10002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - JX10 (1mg/kg)', 'interventionNames': ['Drug: JX10']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 - JX10 (3mg/kg)', 'interventionNames': ['Drug: JX10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 - Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'JX10 Part 2 - (1 or 3 mg/kg)', 'interventionNames': ['Drug: JX10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 - Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'JX10', 'type': 'DRUG', 'description': 'JX10 is a thrombolytic agent.', 'armGroupLabels': ['JX10 Part 2 - (1 or 3 mg/kg)', 'Part 1 - JX10 (1mg/kg)', 'Part 1 - JX10 (3mg/kg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is being used as the comparator.', 'armGroupLabels': ['Part 1 - Placebo', 'Part 2 - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Blagoevgrad', 'status': 'RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 42.01457, 'lon': 23.09804}}, {'city': 'Edmonton', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Baotou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site,', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Kaili', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 26.58583, 'lon': 107.97972}}, {'city': 'Linfen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 36.08889, 'lon': 111.51889}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Suzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Weifang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'city': 'Xuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Altenburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Yamagata', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Kuching', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Kragujevac', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Girona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'information.center@corxelbio.com', 'phone': '201-268-3723'}], 'facility': 'Corxel Investigational Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'centralContacts': [{'name': 'Corxel Pharmaceuticals Study Information Center', 'role': 'CONTACT', 'email': 'Information.center@corxelbio.com', 'phone': '201-268-3723'}], 'overallOfficials': [{'name': 'Senior Director, Clinical Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corxel Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corxel Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}