Role of Omega-DEK in Childhood Apraxia of Speech

NCT ID: NCT07216001

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-07-31

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.

Detailed Description

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. Confusion around this condition is reflected by the vast number of terms used to define it, including Childhood Apraxia of Speech, Developmental Apraxia, Developmental Dyspraxia, Speech Apraxia, and Speech Dyspraxia to name a few.

Approximately half of children with autism spectrum disorders (ASD) have some degree of apraxia, although not all apraxic children are autistic. There is currently no recognized cure for VA, and it is thought to be a life-long condition. Standard treatment is extremely costly and involves intensive and frequent 1:1 speech therapy with a speech pathologist knowledgeable in VA. Typical response to therapy tends to be slow, and some children do not learn how to talk, thereby requiring alternate means of communication. Children with this disorder find it very difficult to correctly pronounce sounds, syllables, and words, despite intense effort. Intelligibility is poor, and some children remain completely speechless and require the use of augmentative communication devices, sign language and/or a picture exchange communication system.

Many children with VA present with a unique but homogeneous group of neurological symptoms that affect coordination, muscle tone and sensory issues in addition to expressive speech delay, suggesting a common underlying mechanism of disease. Vitamin E (vit E) deficiency causes a constellation of symptoms that overlap those of speech apraxia, limb dyspraxia, hypotonia and sensory integration dysfunction (including abnormalities in proprioception, vestibular sensation, and pain interpretation) that often occur in VA and ASD. Low bioavailability of vit E will create an environment within the cell membrane where vital polyunsaturated fatty acids (PUFAs) are vulnerable to lipid peroxidation and early destruction. This can lead to a functional PUFA deficiency and neurological sequelae that may be reversible through supplementation with PUFA/vit E. In addition, PUFA supplementation increases utilization of vit E in the body. These two supplements may have synergistic effects at higher doses.

An unexpected number of apraxic children have a carnitine deficiency, high antigliadin antibodies and carry a gluten-sensitivity major histocompatibility complex (HLA), suggesting abnormal fatty acid metabolism, increased oxidative stress and a potential link to gastrointestinal inflammation and gluten-sensitivity that creates a distinctive nutritional requirement in these children that may benefit from an investigational drug specifically formulated to targets unique deficiencies that contribute to VA. The researchers speculate that patients with gluten sensitivity or those carrying a celiac HLA with autism/VA may not have classic celiac disease, but perhaps a broader diagnosis of gluten-sensitivity associated with malabsorption and neurobehavioral consequences of nutritional deficiencies that needs consideration. The less sensitive celiac biomarker, antigliadin immunoglobulin G (IgG), frequently found in both ASD and VA may represent a biomarker that identifies an intervention-responder group. A recent double-blind randomized, placebo-controlled trial in irritable bowel syndrome concluded that a non-celiac gluten intolerance my exist, a concept in need of exploration in both ASD and VA.

In this study, children between 3 and 6 years old with confirmed childhood apraxia of speech (CAS) will take an investigational drug (Omega-DEK) plus L-carnitine (Carnitor®) for 12 weeks. This open-label period of the study is followed by an 8-week blinded trial where participants will be randomized to continue taking Omega-DEK or to take a placebo.

Conditions

Childhood Apraxia of Speech; Verbal Apraxia; Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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 trial, who are then randomized to continue to receive Omega-DEK for 8 additional weeks.

Group Type: EXPERIMENTAL

Omega-DEK

Intervention Type: DRUG

Participants take 2 capsules, twice daily (BID).

L-carnitine

Intervention Type: DRUG

Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID). L-carnitine is provided to participants only during the 12-week open-label trial.

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

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 trial, who are then randomized to receive a placebo to match Omega-DEK for 8 weeks.

Group Type: EXPERIMENTAL

Omega-DEK

Intervention Type: DRUG

Participants take 2 capsules, twice daily (BID).

L-carnitine

Intervention Type: DRUG

Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID). L-carnitine is provided to participants only during the 12-week open-label trial.

Placebo

Intervention Type: DRUG

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

Interventions

Omega-DEK

Participants take 2 capsules, twice daily (BID).

Intervention Type: DRUG

L-carnitine

Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID). L-carnitine is provided to participants only during the 12-week open-label trial.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Carnitor®

Eligibility Criteria

Inclusion Criteria

1. Confirmed diagnosis of childhood apraxia of speech/verbal apraxia by a qualified professional (SLP) based on established guidelines.

2. Male and female, age 36 months - 6 years (inclusive)

3. Ability to comprehend and use Standard American English

Exclusion Criteria

1. Children unable to tolerate oral supplementation

2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug

3. 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).

4. Known seizure disorder or history of febrile seizures

5. History of cardiac dysrhythmia or abnormal ECG at baseline

6. A prothrombin time test with an international normalised ratio (PT/INR) >1.2.

7. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.

8. A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study

9. 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

10. Recent reintroduction of food items from elimination diet < 3 months

11. 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)

12. Any new chronic medication < 3 months prior to enrollment (stable doses > 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)

13. Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications

14. Plans to try additional complementary interventions or diets during the study period

15. Planned surgery during or within 4 weeks after conclusion of trial

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia R. Morris

OTHER

Sponsor Role: lead

Responsible Party

Claudia R. Morris

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia R Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Lawrence Scahill, MSN,PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Marcus Autism Center

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Claudia R Morris, MD

Role: CONTACT

claudia.r.morris@emory.edu

470-656-2942

Other Identifiers

STUDY00007888

Identifier Type: -

Identifier Source: org_study_id