Last updated on July 2020

A Study to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged Release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attentiondeficit/Hyperactivity Disorder (ADHD)

Brief description of study

This interventional multicenter dose-optimization Phase IV PASS conducted in Europe and the USA evaluates the comparative long-term safety and efficacy of SPD503 in children and adolescents aged 6 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) for whom stimulants are not suitable, not tolerated, or shown to be ineffective.

The study will be conducted in two parts: Study Part A (randomized, double-blinded, parallel-group, placebo- and active comparator-controlled, 3-treatment arm safety and efficacy evaluation of SPD503) and Study Part B (open label SPD503 treatment).

Detailed Study Description

This study will be conducted in two parts Part A and Part B. Part A is a double-blinded, double-dummy, placebo-controlled study with an atomoxetine arm as an active reference to SPD503. Eligible participants will be randomized in a 1:1:1 ratio among SPD503, atomoxetine, and placebo treatment arms for the first 18 weeks of double-blinded treatment. At the end of the first 18 weeks, participants in the placebo treatment arm will rollover to Part B of the study directly for an additional 52 weeks of open-label SPD503 treatment. Participants in the SPD503 and atomoxetine treatment arms will continue in Part A of the study for the remainder of the 52 weeks. At the end of 52 weeks of double-blinded treatment and evaluation in Part A. Participants in the SPD503 and atomoxetine treatment arms will rollover into Part B of the study for an additional 1 year of open-label SPD503 treatment.

26 JUNE 2020: The temporary enrollment stop of new patients into this study due to the COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic.

20 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Clinical Study Identifier: NCT04085172

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Homestead Medical Research

Homestead, FL United States
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Phoenix Medical Research, Inc.

Prairie Village, KS United States
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Alivation Research, LLC

Lincoln, NE United States
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University of Cincinnati

Cincinnati, OH United States
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Family Psychiatry of The Woodlands

The Woodlands, TX United States
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Clinical Research Partners, LLC

Petersburg, VA United States
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LKH Hall

Hall in Tirol, Austria
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ZNA Middelheim

Borgerhout, Belgium
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UZ Leuven

Leuven, Belgium
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EB FlevoResearch

Almere, Netherlands
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Groningen, Netherlands
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EB Utrecht

Utrecht, Netherlands
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Ninewells Hospital

Dundee, United Kingdom
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Lister Hospital

Stevenage, United Kingdom
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Sun Valley Research Center

Imperial, CA United States
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AMR Conventions Research

Naperville, IL United States
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Qualmedica Research, LLC

Owensboro, KY United States
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Cutting Edge Research Group, Inc

Oklahoma City, OK United States
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Recruitment Status: Open

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