Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-02 @ 6:13 AM
Study NCT ID:
NCT00046761
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2002-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C459360', 'term': 'ONO2506'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1320}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2002-10-02', 'studyFirstSubmitQcDate': '2002-10-03', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale'}]}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke'], 'conditions': ['Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in neurological stroke outcome in patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have a clinical diagnosis of acute cortical ischemic stroke.\n* Patient must be randomized into the study within six hours after the initial onset of stroke symptoms.\n* Patient must have a measurable focal neurological deficit for a minimum duration of 60 minutes.\n* Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke.\n* Patient must have had a pre-stroke mRS scale score of 0 or 1.\n* Other inclusion criteria as specified in the study protocol.\n\nExclusion Criteria:\n\n* Patient must not have a body weight of more than 125 kg.\n* Patient must not have a CT and/or MRI with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or primary intracerebral and/or intraventricular hemorrhage.\n* Patient must not have all three of the following findings:\n\n 1. reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a)\n 2. forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and\n 3. dense hemiplegia (no movement) of upper and lower extremities (i.e., has score of 4 on NIHSS Question 5 regarding motor arm and has score of 4 on NIHSS Question 6 regarding motor leg).\n* Patient must not have neurological signs and symptoms that are rapidly improving.\n* Patient must not have a severe coexisting or terminal systemic disease.\n* Patient must not be pregnant or lactating.\n* Patient must not have impaired hepatic function; bilirubin greater than 2 mg/dL and or ascites.\n* Patient must not have impaired renal function; serum creatinine greater than 2 mg/dL.\n* Patient must not have congestive heart failure.\n* Patient must not have a baseline ECG showing a PR interval greater than 200 milliseconds, or a corrected QT interval of greater than 480 milliseconds, or a history of ventricular arrhythmias, or a Mobitz Type 1 or greater AV block.\n* Patient must not have other exclusion criteria as specified in the study protocol.'}, 'identificationModule': {'nctId': 'NCT00046761', 'briefTitle': 'A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '2506/INT0104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ONO-2506', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Brookwood Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Hospital/ Summit Medical Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Grossmont Hospital', 'geoPoint': {'lat': 32.76783, 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