NCT06292520 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J
Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
Maljaars J, Noens I, Scholte E, van Berckelaer-Onnes I
Language in low-functioning children with autistic disorder: differences between receptive and expressive skills and concurrent predictors of language. J Autism Dev Disord. 2012 Oct;42(10):2181-91. doi: 10.1007/s10803-012-1476-1.
Plesa Skwerer D, Jordan SE, Brukilacchio BH, Tager-Flusberg H
Comparing methods for assessing receptive language skills in minimally verbal children and adolescents with autism spectrum disorders. Autism. 2016 Jul;20(5):591-604. doi: 10.1177/1362361315600146. Epub 2015 Sep 25.
Sket GM, Overfeld J, Styner M, Gilmore JH, Entringer S, Wadhwa PD, Rasmussen JM, Buss C
Neonatal White Matter Maturation Is Associated With Infant Language Development. Front Hum Neurosci. 2019 Dec 17;13:434. doi: 10.3389/fnhum.2019.00434. eCollection 2019.

ABLLS-R and Portage Guide in the Development of Receptive Language Skills in Children With Autism Spectrum Disorder.

Clinical trial NCT06292520 - References