Tests Omega-DEK with L-carnitine in young children with childhood apraxia of speech

Trial details

Who runs it

Claudia R. Morris

Trial code

NCT07216001

Record updated

29 July 2026

Original description

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.Read full original descriptionShow less

Role of Omega-DEK in Childhood Apraxia of Speech

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.

Inclusion: Confirmed diagnosis of childhood apraxia of speech/verbal apraxia by a qualified professional (SLP) based on established guidelines; Male and female, age 36 months - 6 years (inclusive); Ability to comprehend and use Standard American English; 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.); Male and female, aged ≥2 years; Ability to comprehend and use Standard American English.

Exclusion: Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug; A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study; On an elimination diet for < 3 months (gluten, casein, yeast free etc.) prior to enrollment, or planning to initiate a special diet during the study; Any new chronic medication < 3 months prior to enrollment (stable doses > 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication); Planned surgery during or within 4 weeks after conclusion of trial; Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug; Medical or genetic condition that in the opinion of the PI/Co-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); Known seizure disorder or history of febrile seizures; History of cardiac dysrhythmia or abnormal ECG at baseline; Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications; History of cardiac dysrhythmia or abnormal ECG at baseline; A prothrombin time test with an international normalised ratio (PT/INR) >1.2; PT-INR >1.2. A clinical lab performed within a month of enrollment will be accepted to meet this exclusion criteria; Children unable to tolerate oral supplementation; Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc; Recent reintroduction of food items from elimination diet < 3 months; On any additional nutritional interventions/supplements < 3 months (i.e. high dose vitamins/minerals that exceed what would be found in a children's multivitamin supplement etc., probiotics); Plans to try additional complementary interventions or diets during the study period; Subjects unable to tolerate oral supplementation; Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. (Symptomatic use of NSAIDS for acute fever or pain permitted).

ClinicalTrials.gov NCT07216001