Not Yet RecruitingPhase 2

Role of Omega-DEK in Childhood Apraxia of Speech

United States34 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range2 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Children unable to tolerate oral supplementation
✕. 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
✕. A prothrombin time test with an international normalised ratio (PT/INR) \>1.2
✕. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.
✕. A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study

What they're measuring

Percent of Participants Retained in Study

Timeframe: Up to Week 20

Percent of Expanded Cohort Recruited

Timeframe: Up to Month 12

Percent of Expanded Cohort Retained

Timeframe: Up to Month 12

Percent of Expanded Cohort Complying with Treatment Regimen

Timeframe: Up to Month 12

Percent of Expanded Cohort With Complete Data

Timeframe: Up to Month 12

Trial details

NCT IDNCT07216001

SponsorClaudia R. Morris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Claudia R Morris, MD

470-656-2942 claudia.r.morris@emory.edu

View on ClinicalTrials.gov More Childhood Apraxia of Speech trials

Plain-language summary

Who can participate

Age range2 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Children unable to tolerate oral supplementation
✕. 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
✕. A prothrombin time test with an international normalised ratio (PT/INR) \>1.2
✕. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.
✕. A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study

What they're measuring

Percent of Participants Retained in Study

Timeframe: Up to Week 20

Percent of Expanded Cohort Recruited

Timeframe: Up to Month 12

Percent of Expanded Cohort Retained

Timeframe: Up to Month 12

Percent of Expanded Cohort Complying with Treatment Regimen

Timeframe: Up to Month 12

Percent of Expanded Cohort With Complete Data

Timeframe: Up to Month 12