Summary

Children with Down Syndrome (DS) often require chronic medications for various co-occurring conditions. However, there is limited knowledge about how these medications work in children with DS. This study aims to investigate how Guanfacine Immediate Release (GIR) affects children with DS who have hyperactivity/ADHD and inattention, specifically focusing on efficacy and safety outcomes.

Approximately 60 children with DS and hyperactivity/ADHD and inattention, aged 6-12 years old, will be enrolled and randomized 2:1 to GIR or placebo. Neither the study doctor or participant/family will know the assignment until the end of the study. GIR or placebo dosing will start at 0.5 mg, which is less than commercially available tablets, and the capsule may be opened and sprinkled into a small amount of soft food. Dosing may be increased weekly based on the participant’s progress. There are three in-person visits, as well as weekly phone calls. The study involves three blood draws, three ECGs, and questionnaires about the child’s hyperactivity symptoms, other behaviors, and sleep patterns.

Participants will be unmasked after 8 weeks of GIR or placebo administration. Those who received GIR can choose to continue with open-label GIR per standard care or taper off of GIR.

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