[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Saol Therapeutics Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100610336","phase-3-phase-iii-study-to-assess-the-safety-and-efficacy-of-sl1002-for-osteoarthritis-knee-pain-100610336",false,"NCT07226258","Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain","A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee","Inclusion Criteria includes:\n\n1. Male or female patients ≥ 40 years of age\n2. Body Mass Index (BMI) limits\n3. Chronic knee pain resulting from osteoarthritis\n4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)\n5. Baseline KOOS pain\n6. Patients taking baseline analgesics\n7. Diagnostic nerve block response\n8. Compliance with identified study requirements\n\nExclusion Criteria includes:\n\n1. Non-OA inflammatory arthritis\n2. Confounding elements\n3. Lower limb amputation.\n4. Specified alternate historic treatments\n5. Identified underlying physiologic or psychosocial conditions\n6. Patient Health Questionnaire\n7. Moderate to severe hepatic impairment\n8. Moderate to severe renal impairment\n9. Identifiable baseline medications\n10. Protocol compliance requirements\n11. Known allergies or hypersensitivity to identified agents\n12. Identified alcohol or drug abuse history\n13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment\n14. Identified underlying abnormal laboratory results","ALL","40 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.",[26],"Osteoarthritis Knee Pain","RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-23","ACTUAL",{"date":33,"type":31},"2025-11-07",{"date":35,"type":20},"2027-02-28",{"name":37,"class":38},"Saol Therapeutics Inc","INDUSTRY",21,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":4,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":59,"locationsCount":4},"100587659","expanded-access-treatment-protocol-with-dca-for-patients-with-pdcd-100587659","NCT06931262","Expanded Access Treatment Protocol With DCA for Patients With PDCD","Expanded Access Treatment Protocol With Dichloroacetate Sodium for Patients With Pyruvate Dehydrogenase Complex Deficiency","Inclusion Criteria:\n\n1. Ages 0 through adulthood\n2. Presence of characteristic clinical or metabolic features of PDCD and\n3. Presence of a known pathogenic mutation of a gene that is specifically associated with PDC (PDHA1, PDHB, DLAT, PDHX, DLD).\n4. Females of reproductive age must be willing to use an effective method of barrier contraception for the duration of the study.-\n\nExclusion Criteria:\n\n1. A genetic mitochondrial disease other than those stipulated under inclusion criteria\n2. Primary, defined organic acidurias other than lactic acidosis (e.g., propionic aciduria)\n3. Primary disorders of amino acid metabolism\n4. Primary disorders of fatty acid oxidation\n5. Secondary lactic acidosis due to impaired oxygenation or circulation (e.g., due to severe cardiomyopathy or congenital heart defects)\n6. Malabsorption syndromes associated with D-lactic acidosis\n7. Renal insufficiency, defined as 1) a requirement for chronic dialysis or 2) serum creatinine ≥ 1.2 mg\u002Fdl or creatinine clearance \\\u003C60 ml\u002Fmin\n8. Primary hepatic disease unrelated to PDCD\n9. Pregnancy or breast feeding -","0 Years","17 Years","EXPANDED_ACCESS","Expanded Access (EA) will provide a transition to continue therapy for those patients who are currently in the open label extension of the Phase III study, SL 1009-01, while also allowing new patients diagnosed with PDCD who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable.",[52],"Pyruvate Dehydrogenase Complex Deficiency",[54],"PDCD","AVAILABLE","2025-05-05",{"date":58,"type":31},"2025-05-08",{"name":37,"class":38},""]