[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Claudia R. Morris\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100609547","phase-2-role-of-omega-dek-in-childhood-apraxia-of-speech-100609547",false,"NCT07216001","Role of Omega-DEK in Childhood Apraxia of Speech","Inclusion Criteria:\n\n1. Confirmed diagnosis of childhood apraxia of speech\u002Fverbal apraxia by a qualified professional (SLP) based on established guidelines\n2. Male and female, age 36 months - 6 years (inclusive)\n3. Ability to comprehend and use Standard American English\n\nExclusion Criteria:\n\n1. Children unable to tolerate oral supplementation\n2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug\n3. Medical or genetic condition that in the opinion of the PI\u002FCo-Is may affect participation and compromise results (including significant receptive language delay, moderate-severe cognitive delay, complex medical history, hearing loss, cerebral palsy, history of traumatic brain injury or severe anoxic event, Down's syndrome)\n4. Known seizure disorder or history of febrile seizures\n5. History of cardiac dysrhythmia or abnormal ECG at baseline\n6. A prothrombin time test with an international normalised ratio (PT\u002FINR) \\>1.2\n7. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.\n8. A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study\n9. On an elimination diet for \\\u003C 3 months (gluten, casein, yeast free etc.) prior to enrollment, or planning to initiate a special diet during the study\n10. Recent reintroduction of food items from elimination diet \\\u003C 3 months\n11. On any additional nutritional interventions\u002Fsupplements \\\u003C 3 months (i.e. high dose vitamins\u002Fminerals that exceed what would be found in a children's multivitamin supplement etc., probiotics)\n12. Any new chronic medication \\\u003C 3 months prior to enrollment (stable doses \\> 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)\n13. Anticipated initiation of new chronic medication during study timeline including new attention-deficit\u002Fhyperactivity disorder (ADHD) medications, other behavior medications\n14. Plans to try additional complementary interventions or diets during the study period\n15. Planned surgery during or within 4 weeks after conclusion of trial\n\nInclusion Criteria for Expanded Cohort:\n\n1. Working Diagnosis of CAS, or intestinal lymphangiectasia, or fat malabsorption syndrome (in isolation or associated with other medical conditions such as cystic fibrosis, celiac disease, etc.)\n2. Male and female, aged ≥2 years\n3. Ability to comprehend and use Standard American English\n\nExclusion Criteria for Expanded Cohort:\n\n1. Subjects unable to tolerate oral supplementation\n2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug\n3. History of cardiac dysrhythmia or abnormal ECG at baseline\n4. PT-INR \\>1.2. A clinical lab performed within a month of enrollment will be accepted to meet this exclusion criteria\n5. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. (Symptomatic use of NSAIDS for acute fever or pain permitted)","ALL","2 Years","6 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a 20-week study for children between 3 and 6 years old with confirmed childhood apraxia of speech (CAS). The study includes a 12-week open-label pilot feasibility study of an investigational drug (Omega-DEK) plus L-carnitine (Carnitor®), which is followed by an 8-week randomized, placebo-controlled discontinuation period among the same study participants.",[26,27,28],"Childhood Apraxia of Speech","Verbal Apraxia","Autism","NOT_YET_RECRUITING","2026-02-24",{"date":32,"type":33},"2026-02-27","ACTUAL",{"date":35,"type":20},"2026-05",{"date":37,"type":20},"2027-12",{"name":39,"class":40},"Claudia R. Morris","OTHER",2,""]