drugset / Trial / NCT07216001

Role of Omega-DEK in Childhood Apraxia of Speech

NCT07216001

Phase 2 Not yet recruiting 34 enrolled Claudia R. Morris
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-05
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Omega-DEK Unknown
Background L-carnitine Other / unclassified 2.5 ml Oral
Background L-carnitine Other / unclassified 250 mg Oral