Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT03223220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2017-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quelling of Excitotoxicity in Acute Stroke With Ketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': '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': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.', 'timeFrame': 'On day 1 and at 90 days', 'description': 'An improvement of 2 in mRS score will be considered favorable outcome.'}], 'secondaryOutcomes': [{'measure': "Barthel's index", 'timeFrame': 'On day 1, and at 90 days', 'description': "An improvement of 10 or more points in Barthel's index will be considered a favorable outcome."}, {'measure': 'NIH stroke scale score', 'timeFrame': 'On day 1, day 4 or discharge whichever is earlier, and at 90 days'}, {'measure': 'Depression score using the PHQ9 questionnaire', 'timeFrame': 'On day 1, and day 4 or discharge whichever is earlier.'}, {'measure': 'Infarct volumes', 'timeFrame': 'On day 1, and day 4 or discharge whichever is earlier', 'description': 'Measured from the DWI-MRI and/or CT images'}, {'measure': 'All cause mortality', 'timeFrame': '90 days'}, {'measure': 'Stroke-related mortality', 'timeFrame': '90 days'}, {'measure': 'Symptomatic intracranial hemorrhage', 'timeFrame': 'Day 4 or discharge whichever is earlier'}, {'measure': 'Deterioration in neurologic status', 'timeFrame': 'Up to day 4 or discharge whichever is earlier', 'description': 'Increase of 4 or more points in the NIH stroke scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke, Neuroprotection, Ketamine'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.', 'detailedDescription': "After obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive Ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 20 mg/h for a period of 24 hours. The infusion will start at a rate of 5 mg/h, and then gradually tapered up during the first 3 hours by 5 mg an hour. Similarly, the infusion rate will be gradually tapered down at a rate of 5 mg/h during the last 3 hours of infusion. The patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. In order to prevent the psychogenic adverse effects associated with Ketamine, the patients will be administered Midazolam at a dose of 1 mg IV every 4 hours. Midazolam will also be administered at the same rate to the patients randomized to the placebo arm. Blood Ketamine levels will be measured before starting the treatment, and daily while the infusion is on. While receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time\n2. An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate\n3. Pre-stroke modified Rankin scale of 0-2\n4. Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy.\n\nExclusion Criteria:\n\n1. Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy\n2. Longer than 24 hours since last known well time\n3. Pre-stroke modified Rankin scale of 3 or above.\n4. Pregnant or lactating females\n5. Pre-existing psychiatric illness\n6. Intracranial hemorrhage of any type at presentation\n7. Seizure at onset of symptoms\n8. Sustained uncontrolled hypertension defined as Systolic Blood pressure greater than 185 mmHg or Diastolic Blood Pressure greater than 110 mmHg, despite administration of antihypertensive medications\n9. Known hypersensitivity or adverse reaction to prior administration of Ketamine\n10. Inability/refusal to provide consent by the patient or through a proxy'}, 'identificationModule': {'nctId': 'NCT03223220', 'acronym': 'QUEST-KETA', 'briefTitle': 'Quelling of Excitotoxicity in Acute Stroke With Ketamine', 'organization': {'class': 'OTHER', 'fullName': 'Lower Merion Neurology Research Foundation'}, 'officialTitle': 'Quelling of Excitotoxicity in Acute Stroke With Ketamine', 'orgStudyIdInfo': {'id': 'LMNRF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Drug', 'description': 'Will receive Ketamine infusion, and Midazolam (Versed).', 'interventionNames': ['Drug: Ketamine', 'Drug: Midazolam injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Will receive Normal saline infusion and Midazolam (Versed).', 'interventionNames': ['Other: Normal Saline', 'Drug: Midazolam injection']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Study Drug']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'IV infusion', 'armGroupLabels': ['Placebo']}, {'name': 'Midazolam injection', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': 'Injection', 'armGroupLabels': ['Placebo', 'Study Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Sudhir Aggarwal, MD, PhD', 'role': 'CONTACT', 'email': 'saggarwal@lowermerionneurology.com', 'phone': '484-413-2572'}], 'facility': 'Lankenau Medical Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}], 'centralContacts': [{'name': 'Sudhir Aggarwal, MD, PhD', 'role': 'CONTACT', 'email': 'saggarwal@lowermerionneurology.com', 'phone': '4844132572'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lower Merion Neurology Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurologist and Medical Director', 'investigatorFullName': 'Sudhir Aggarwal MD, PhD,', 'investigatorAffiliation': 'Lower Merion Neurology Research Foundation'}}}}