NCT03662763

Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity

Phase 3,Double Blind,Placebo-controlled,Multicentre,Randomised-withdrawal,Long-term Maintenance of Efficacy&Safety Study of Extended-release Guanfacine Hydrochloride in Children/Adolescents Aged 6-17 With ADHD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and the US.

Detailed description

The SPD503-315 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of ADHD in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-termn, open-label studies. This study will more rigorously assess the long-term maintenance of efficacy using a placebo-controlled, randomised-withdrawal design. To date, all of the completed studies conducted as part of the SPD503 proigram have enrolled subjects from the US. This study is designed to evaluate the long-term maintenance of efficacy of SPD503 for the treatment of ADHD in children aged 6-17 years in Europe, Australia, Canada and US.

Conditions

• Attention Deficit Disorder

Interventions

Type	Name	Description
DRUG	Extended-release Guanfacine Hydrochloride (SPD503)	dosing in all subjects will initiate with 1mg/day, and may be increased by 1 mg increments after a minimum of 1 week on the current dose to the maximum doses based on age and weight.
DRUG	Placebo oral capsule

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2018-09-07
• Last updated: 2018-09-07

Locations

1 site across 1 country: Netherlands