Role of Omega-DEK in Childhood Apraxia of Speech

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Claudia R. Morris
Study ID
NCT07216001
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Autism
  • Childhood Apraxia of Speech
  • Verbal Apraxia

Eligibility Criteria

Sex
ALL
Age
2 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Omega-DEK — DRUG
    Participants take 2 capsules, twice daily (BID).
  • L-carnitine — DRUG
    Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID).
  • Placebo — DRUG
    A placebo of palm kernel oil to match Omega-DEK is provided. Participants take 2 capsules, twice daily (BID).

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 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.
  • Experimental: 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 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.
  • Experimental: Expanded Cohort
    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.

Primary Outcome Measure

Percent of Participants Retained in Study [ Time Frame: Up to Week 20 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Marcus Autism CenterAtlantaGeorgia30329-

Find similar trials in Atlanta, GA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Children's Healthcare of Atlanta· Atlanta, GAMarcus Autism Center· Atlanta, GA

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