Role of Omega-DEK in Childhood Apraxia of Speech
Claudia R. Morris
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.
Description
Verbal apraxia (VA) is a severe neurological motor planning speech disorder of unknown etiology. It is a devastating disorder that is insufficiently recognized by general pediatricians and often goes unaddressed and improperly treated during critical years of speech and language development. The high prevalence of this disorder excludes it as an "orphan" disease, although like autism, it may have met the definition over a decade ago. However, inadequate awareness of this condition among practitioners renders it a neglected disorder. Confusion around this condition is reflected by the vast numb…
Eligibility
- Age range
- 2–6 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Confirmed diagnosis of childhood apraxia of speech/verbal apraxia by a qualified professional (SLP) based on established guidelines 2. Male and female, age 36 months - 6 years (inclusive) 3. Ability to comprehend and use Standard American English Exclusion Criteria: 1. Children unable to tolerate oral supplementation 2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug 3. Medical or genetic condition that in the opinion of the PI/Co-Is may affect participation and compromise results (including significant receptive language delay,…
Interventions
- DrugOmega-DEK
Participants take 2 capsules, twice daily (BID).
- DrugL-carnitine
Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID).
- DrugPlacebo
A placebo of palm kernel oil to match Omega-DEK is provided. Participants take 2 capsules, twice daily (BID).
Locations (2)
- Children's Healthcare of AtlantaAtlanta, Georgia
- Marcus Autism CenterAtlanta, Georgia