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Role of Omega-DEK in Childhood Apraxia of Speech

NCT07216001 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Childhood Apraxia of Speech
  • Verbal Apraxia
  • Autism

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).

Sponsors & Collaborators

  • Claudia R. Morris

    lead OTHER

Principal Investigators

  • Claudia R Morris, MD · Emory University

  • Lawrence Scahill, MSN,PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07216001 on ClinicalTrials.gov