drugset / Trial / NCT01098383

Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism Spectrum Disorders

NCT01098383

RandomizedCrossoverQuadruple-blindTreatment

Summary

We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.

Timeline

Start
2010-03
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Choline Other / unclassified 250 mg Oral
Subject Choline Other / unclassified 500 mg Oral
Subject Donepezil Small molecule 5 mg Oral

Indications