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NOT YET RECRUITING
NCT07216001
PHASE2

Role of Omega-DEK in Childhood Apraxia of Speech

Sponsor: Claudia R. Morris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-05

Completion Date

2027-12

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

Omega-DEK

Participants take 2 capsules, twice daily (BID).

DRUG

L-carnitine

Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID).

DRUG

Placebo

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 Atlanta

Atlanta, Georgia, United States

Marcus Autism Center

Atlanta, Georgia, United States