[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stroke-embolic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stroke-embolic":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100442801","phase-2-mlc1501-study-assessing-efficacy-in-stroke-recovery-100442801",false,"NCT05046106","MLC1501 Study Assessing Efficacy in STROke Recovery","A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Efficacy and Safety Study of MLC1501 in Patients With Stroke","MAEStro","Inclusion Criteria:\n\n* Male or female.\n* 18 years old or older.\n* Diagnosed with acute ischemic stroke with compatible brain imaging findings between 2 days to 7 days prior to inclusion. Patients who undergo intravenous or endovascular thrombolysis or thrombectomy must be considered stable for at least 24 hours post-procedure prior to inclusion.\n* NIHSS total score of 8 to 18 (inclusive) at the time of inclusion with a combined score of at least 2 on the NIHSS motor items 5A or 5B and\u002For 6A or 6B.\n* A candidate for active rehabilitation in the opinion of the treating physician.\n* Able to comply with the requirements of the protocol and provide written informed consent by patient or legal representative before any study-specific procedure is performed.\n\nExclusion Criteria:\n\n* Pre-stroke modified Rankin score of \\>1.\n* Contraindication to any of the study procedures.\n* Participation in another investigational drug or device trial within the past 30 days.\n* Intake of warfarin in the past one week or expected to be on warfarin while in the study.\n* Women who are pregnant, breastfeeding, of child-bearing potential or planning to become pregnant during the study. Menopausal\u002Fpost-menopausal women without menstruation for 12 consecutive months or surgically sterilized women may be included. Intake of oral contraceptive pills or hormone replacement therapy is not allowed. Use of mechanical barriers, e.g., condom, intrauterine device, are allowed. Local contraception requirements for clinical trials should be followed.\n* Any known food allergy or hypersensitivity to Astragalus membranaceus, Ligusticum chuanxiong, Polygala tenuifolia, Angelica sinensis, or members of the Fabaceae\u002FLeguminosae family (e.g., legume, pea, bean), Polygalaceae family (e.g., milkwort, snakeroot), Apiaceae\u002FUmbelliferae family (e.g., anise, caraway, carrot, celery, dill, parsley, parsnip), or Quillaja bark (soapbark).\n* Evidence of other significant non-ischemic brain lesion which could affect long-term function or disability.\n* Evidence of advanced medical condition that would affect study assessment and follow-up, such as cancer, renal failure, liver cirrhosis, severe dementia, or psychosis.\n* Any other medical or psychiatric or cognitive condition which, in the study investigator's opinion, may jeopardize the patient by his\u002Fher participation in this study, may hamper his\u002Fher ability to complete procedures required in the study, affect study assessment and follow-up, or affect the validity of the study results","ALL","18 Years",{"count":20,"type":21},540,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This is a multi-center, randomized, double-blind, placebo-controlled, dose-response study of MLC1501 in patients with stroke. Eligible participants will be randomized in a 1:1:1 ratio to orally receive MLC1501 low-dose twice a day, MLC1501 high-dose twice a day, or matching placebo for 24 weeks.",[28,29,30,31,32,33,34],"Stroke","Stroke, Ischemic","Strokes Thrombotic","Stroke Sequelae","Stroke, Cardiovascular","Stroke, Embolic","Stroke, Cryptogenic",[36,37,15,38,39],"stroke","MLC1501","stroke recovery","neurorestoration","NOT_YET_RECRUITING","2023-03-14",{"date":43,"type":44},"2023-03-16","ACTUAL",{"date":46,"type":21},"2025-01",{"date":48,"type":21},"2028-12",{"name":50,"class":51},"Moleac Pte Ltd.","INDUSTRY"]