Role of Omega-DEK in Childhood Apraxia of Speech

What Was Tested

The trial (phase 2) is built around L-Carnitine.

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.

It had three arms (groups): Omega-DEK and L-carnitine for 12 Weeks Followed by Omega-DEK for 8 Weeks (experimental), Omega-DEK and L-carnitine for 12 Weeks Followed by Placebo for 8 Weeks (experimental) and Expanded Cohort (experimental).

Children aged 3 to 6 years old with confirmed childhood apraxia of speech (CAS) receiving Omega-DEK and L-carnitine for the 12-week open-label part of the trial, who are then randomized to continue to receive Omega-DEK for 8 additional weeks. L-carnitine is provided to participants only during the 12-week open-label portion of the trial.

Children aged 3 to 6 years old with confirmed childhood apraxia of speech (CAS) receiving Omega-DEK and L-carnitine for the 12-week open-label part of the trial, who are then randomized to receive a placebo to match Omega-DEK for 8 weeks. L-carnitine is provided to participants only during the 12-week open-label portion of the trial.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

34 planned participants were the target.

It was open to people of any sex aged from 36 months up to 6 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 23 exclusion criteria; among the exclusions: children unable to tolerate oral supplementation; known allergy to fish oil, palm kernel oil or other ingredients in investigational drug; known seizure disorder or history of febrile seizures.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-11 with completion listed for 2027-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent of Participants Retained in Study (time frame: Up to Week 20). Percent of Expanded Cohort Recruited (time frame: Up to Month 12). Percent of Expanded Cohort Retained (time frame: Up to Month 12).

It also tracked 4 secondary outcomes, for example Percent of Participants With Complete Outcome Data, Change in Dynamic Evaluation of Motor Speech Skill (DEMSS) Score and Mean Length of Utterances (MLU).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 34 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.