Role of Omega-DEK in Childhood Apraxia of Speech

NCT07216001 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY000078882025P010775
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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

Verbal Apraxia; Autism; Childhood Apraxia of Speech

Outcome Measures

Primary Outcomes (5)

• Percent of Participants Retained in Study

  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.

  Up to Week 20

• Percent of Expanded Cohort Recruited

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

  Up to Month 12

• Percent of Expanded Cohort Retained

  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.

  Up to Month 12

• Percent of Expanded Cohort Complying with Treatment Regimen

  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.

  Up to Month 12

• Percent of Expanded Cohort With Complete Data

  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.

  Up to Month 12

Secondary Outcomes (4)

• Percent of Participants With Complete Outcome Data

  Up to Week 20

• Change in Dynamic Evaluation of Motor Speech Skill (DEMSS) Score

  Baseline, Week 12, Week 20

• Mean Length of Utterances (MLU)

  Baseline, Week 12, Week 20

• Clinical Global Impression for Improvement Scale (CGI-I) Score

  Weeks 1, 4, 8, 12 (during the open-label portion of the study), weekly during Weeks 13-22 (during the randomized portion of the study)

Study Arms (3)

Omega-DEK and L-carnitine for 12 Weeks Followed by Omega-DEK for 8 Weeks

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.

Drug: Omega-DEK; Drug: L-carnitine

Omega-DEK and L-carnitine for 12 Weeks Followed by Placebo for 8 Weeks

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 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.

Drug: Omega-DEK; Drug: L-carnitine; Drug: Placebo

Expanded Cohort

EXPERIMENTAL

Children aged 2 or older with a working diagnosis of CAS, intestinal lymphangiectasia, or a fat malabsorption syndrome (in isolation or associated with other medical conditions) receiving Omega-DEK and L-carnitine for 12 months.

Drug: Omega-DEK; Drug: L-carnitine

Interventions

Omega-DEK DRUG

Participants take 2 capsules, twice daily (BID).

Expanded Cohort; Omega-DEK and L-carnitine for 12 Weeks Followed by Omega-DEK for 8 Weeks; Omega-DEK and L-carnitine for 12 Weeks Followed by Placebo for 8 Weeks

L-carnitine DRUG

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

Also known as: Carnitor®

Expanded Cohort; Omega-DEK and L-carnitine for 12 Weeks Followed by Omega-DEK for 8 Weeks; Omega-DEK and L-carnitine for 12 Weeks Followed by Placebo for 8 Weeks

Placebo DRUG

A placebo of palm kernel oil to match Omega-DEK is provided. Participants take 2 capsules, twice daily (BID).

Omega-DEK and L-carnitine for 12 Weeks Followed by Placebo for 8 Weeks

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children unable to tolerate oral supplementation
• Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug
• Medical or genetic condition that in the opinion of the PI/Co-Is may affect participation and compromise results (including significant receptive language delay, moderate-severe cognitive delay, complex medical history, hearing loss, cerebral palsy, history of traumatic brain injury or severe anoxic event, Down's syndrome)
• Known seizure disorder or history of febrile seizures
• History of cardiac dysrhythmia or abnormal ECG at baseline
• A prothrombin time test with an international normalised ratio (PT/INR) \>1.2
• Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.
• A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study
• On an elimination diet for \< 3 months (gluten, casein, yeast free etc.) prior to enrollment, or planning to initiate a special diet during the study
• Recent reintroduction of food items from elimination diet \< 3 months
• On any additional nutritional interventions/supplements \< 3 months (i.e. high dose vitamins/minerals that exceed what would be found in a children's multivitamin supplement etc., probiotics)
• Any new chronic medication \< 3 months prior to enrollment (stable doses \> 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)
• Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications
• Plans to try additional complementary interventions or diets during the study period
• Planned surgery during or within 4 weeks after conclusion of trial

Sponsors & Collaborators

• Claudia R. Morris: lead

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Apraxias; Autistic Disorder

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Claudia R Morris, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Lawrence Scahill, MSN,PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia R Morris, MD

CONTACT

470-656-2942; claudia.r.morris@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study has a 12-week open-label trial of Omega-DEK plus L-carnitine followed by an 8-week placebo-controlled discontinuation where participants are randomized to continue Omega-DEK or take a placebo. A third study arm is for an open-label trial with a cohort of 10 participants taking Omega-DEK plus L-carnitine and have expanded follow-up of 12 months.

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing following publication of the primary and secondary outcomes for this study.
• Access Criteria: Researchers wanting to share data from this study will need to submit a proposal for their planned research to Dr. Morris at claudia.r.morris@emory.edu.

Locations

US (2)