Guanfacine for Hyperactivity in Children with Down Syndrome (HYPEbeGONE_DS)
The purpose of this study is to determine efficacy of guanfacine immediate release (GIR) for the treatment of hyperactivity/impulsivity and inattention in children 6-12 years of age with Down syndrome (DS) after 8 weeks of treatment.
• Parent/Legal Guardian can understand the consent process and is willing to provide informed consent/HIPAA authorization prior to the conduct of any study-related procedures. When applicable, the minor participant is willing to provide assent.
• Participant has clinical diagnosis of non-mosaic DS.
• Participant is between 6 and 12 years of age (inclusive) at time of consent.
• Participant weight is ≥ 25 kg.
• Participant has clinically significant symptoms of hyperactivity, inattention and impulsivity manifested as minimum scores of the following rating scales within 30 days of randomization:
‣ A minimum score of 18 on the parent-reported ABC-H subscale, AND
⁃ A minimum score of moderate or greater (≥ 4) on the clinician reported Clinical Global Impression Severity (CGI-S) score specific to hyperactivity, inattention and impulsivity behaviors.
• Participant has co-morbid medical screening and clearance to proceed with a non-stimulant medication trial with GIR within 30 days of randomization.
• Participant is willing and able to comply with study procedures, including adherence to medication dosing schedule.