Viewing Study NCT06042257



Ignite Creation Date: 2024-05-06 @ 7:32 PM
Last Modification Date: 2024-10-26 @ 3:08 PM
Study NCT ID: NCT06042257
Status: RECRUITING
Last Update Posted: 2024-07-03
First Post: 2023-07-31

Brief Title: Guanfacine for Hyperactivity in Children with Down Syndrome HYPEbeGONE_DS
Sponsor: Rachel G Greenberg MD MB MHS
Organization: Duke University

Study Overview

Official Title: Guanfacine for Hyperactivity in Children with Down Syndrome HYPEbeGONE_DS
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HYP01
Brief Summary: The purpose of this study is to determine efficacy of guanfacine immediate release GIR for the treatment of hyperactivityimpulsivity and inattention in children 6-12 years of age with Down syndrome DS after 8 weeks of treatment
Detailed Description: This is a randomized double-blind placebo-controlled flexibly dosed trial of guanfacine immediate release GIR in children with Down syndrome DS and symptoms of hyperactivity inattention and impulsivity Participants will undergo a screening period of up to 29 days Eligible participants meeting study criteria will be randomized 21 GIR or placebo There are a total of up to 4 in person visits screening baseline at Week 4 and at Week 8 Participants will receive GIR or placebo for up to 8 weeks Weekly dose escalation will be determined via a telephone assessment at Weeks 1-3 and Weeks 4-7 Unmasking of participant and site staff will occur at the week 8 in-person visit After unmasking participants who were randomized to receive GIR will be given the option to 1 remain on GIR and to transition to open-label GIR per standard of care or 2 taper off of GIR A Telephone Safety Assessment will be conducted for all participants at 5 2 days after final study product administration Blood specimens will be collected at the Week 4 and Week 8 visits for Pharmacokinetic PK analyses and lab assessments Participants will be asked to keep a daily study diary and will complete study measures at screeningbaseline Week 4 and Week 8 ParentsCaregivers will need to complete the Study Diary during the bridgetaper period for those who are in the GIR arm

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
HHSN275201800003I OTHER_GRANT National Institute of Child Health and Human Development None