Role of Omega-DEK in Childhood Apraxia of Speech
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-6
SponsorClaudia R. Morris
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Omega-DEK
- L-carnitine
- Placebo
Treatment groups
34 Participants
are divided into 3 treatment groupsSponsors and collaborators
Claudia R. Morris
Lead sponsor
Emory University
Sponsor institution
Source ClinicalTrials.gov