Back to search results

Study of Omega-DEK and L-carnitine for Childhood Apraxia of Speech

This 20-week study is for children aged 3 to 6 years old who have been diagnosed with childhood apraxia of speech (CAS), also known as verbal apraxia. Researchers are studying the role of Omega-DEK and L-carnitine in treating this condition. The study first involves a 12-week period where participants receive Omega-DEK and L-carnitine. This is followed by an 8-week period where some participants will continue with the study drugs and others will receive a placebo (an inactive substance like palm kernel oil). The main goals are to see how many participants stay in the study and how many are recruited and retained in the larger group. You can join if you have a confirmed diagnosis of CAS and can understand and use Standard American English. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 34 participants. It includes a 12-week open-label pilot feasibility study followed by an 8-week randomized, placebo-controlled discontinuation period.
What's involved
Participants will take Omega-DEK capsules and L-carnitine oral solution twice daily. The study lasts for 20 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for retention in the study for up to 20 weeks, and for recruitment and retention in an expanded group for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216001

Role of Omega-DEK in Childhood Apraxia of Speech

Not Yet Recruiting
PHASE2Ages 36–6InterventionalTreatment
Claudia R. Morris
~34 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Omega-DEKL-carnitinePlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of Participants Retained in Study
Measured over Up to Week 20
+4 more outcomes measured

Conditions

Childhood Apraxia of Speech
Verbal Apraxia
Autism

Explore related trials

Celiac DiseaseChildhood apraxia of speechCystic FibrosisIntestinal lymphangiectasisMalabsorption Syndrome

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Claudia R Morris, MD · PRINCIPAL_INVESTIGATOR · Emory University
  • Lawrence Scahill, MSN,PhD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Claudia R Morris, MD
[email protected]
470-656-2942
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Percent of Participants Retained in StudyUp to Week 20

    Feasibility of the intervention is assessed with the percentage of enrolled participants who complete the 20 week study. Successful retention is defined as \>85% of enrolled participants completing the study.

  • Percent of Expanded Cohort RecruitedUp to Month 12

    Feasibility of conducting a 12-month, open-label trial is measured by successful recruitment, which is defined as \<20% refusal of eligible children.

  • Percent of Expanded Cohort RetainedUp to Month 12

    Feasibility of conducting a 12-month, open-label trial is measured by successful retention, which is defined as \>85% of study participants completing the study.

  • Percent of Expanded Cohort Complying with Treatment RegimenUp to Month 12

    Feasibility of conducting a 12-month, open-label trial is measured by successful compliance, which is defined as \>75% of participants with compliance with the treatment regimen.

  • Percent of Expanded Cohort With Complete DataUp to Month 12

    Feasibility of conducting a 12-month, open-label trial is measured by collection of study data, which is defined as \>90% of participants providing outcome data.