A Phase 2 interventional study of Omega-DEK and L-carnitine in Childhood Apraxia of Speech, Verbal Apraxia and Autism, sponsored by Claudia R. Morris. Not yet recruiting at 2 sites in United States. Open to participants aged 36 Months to 6 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Claudia R. Morris · Phase 2, Interventional, and Treatment
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.
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. Additionally, 10 participants will be enrolled in a cohort with expanded follow-up to examine the feasibility of conducting a 12-month open-label trial of Omega-DEK plus L-carnitine in participants aged ≥2 years who have a working diagnosis of CAS, intestinal lymphangiectasia, or fat malabsorption syndrome (in isolation or associated with other medical conditions such as cystic fibrosis, celiac disease, etc.).
65 studies on the registry are indexed under Apraxias; 21 are open to participants now.
This study's planned enrollment of 34 is close to the median of 32 across 50 interventional studies indexed under Apraxias.
Browse Apraxias studies →Claudia R. Morris is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Inclusion Criteria for Main Trial:
Exclusion Criteria for Main Trial:
Inclusion Criteria for Expanded Cohort:
Exclusion Criteria for Expanded Cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Participants take 2 capsules, twice daily (BID).
Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID).
Also known as: Carnitor®
A placebo of palm kernel oil to match Omega-DEK is provided. Participants take 2 capsules, twice daily (BID).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Month 12
Percent of Participants With Complete Outcome Data
Feasibility of the intervention is assessed with the percentage of participants who complete all surveys and study visits. Successful collection of outcome data is defined as \>90% of participants completing study surveys and visits.
Time frame: Up to Week 20
Change in Dynamic Evaluation of Motor Speech Skill (DEMSS) Score
The Dynamic Evaluation of Motor Speech Skill (DEMSS) is a validated tool specifically designed to identify the level of breakdown in a child's ability to speak so that treatment can be established, and improvement tracked. The DEMSS is comprised of 9 subtests with a total of 66 utterances which are associated with 171 items. Four subscores for overall articulatory accuracy of the word, vowel accuracy, prosodic accuracy, and consistency, are calculated. An overall score is calculated and ranges from 0 to 426, where lower scores suggest that CAS is present. Within a clinical setting, scores between 0 and 323 indicate CAS, scores between 323 and 373 indicate mild evidence of mild CAS, and scores of 373 to 426 indicate little or no evidence of CAS. Baseline scores are compared to scores at Week 12, for analysis of the open-label portion of the study, while Week 12 and Week 20 scores are compared for analysis of the randomized discontinuation portion of the study.
Time frame: Baseline, Week 12, Week 20
Mean Length of Utterances (MLU)
Mean length of utterance (MLU) is an assessment of expressive language measures the average number of morphemes per utterance. Morphemes are smallest language elements that make up linguistic expression. A spontaneous speech sample will be obtained and MLU is calculated as the number of morphemes in each utterance divided by the total number of utterances.
Time frame: Baseline, Week 12, Week 20
Clinical Global Impression for Improvement Scale (CGI-I) Score
The CGI-I is a 7-point scale designed to measure overall improvement from baseline. The CGI-I is rated by an independent evaluator who is blind to treatment assignment during the randomized discontinuation phase. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). Positive response to treatment (an improvement from baseline) is defined by a rating of Much Improved or Very Much Improved. Scores of 3 (minimally improved), 4 (no change) and 5 (minimally worse) indicate no change. Scores of 6 or 7 are considered as a worsening of symptoms from baseline (a negative response).
Time frame: 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)
Plan to share: Yes — De-identified individual participant data for study outcomes and demographics will be made available for sharing with other researchers.
Supporting information: 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.
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Claudia R. Morris