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EPA-0685 – Guanfacine XR (GXR) for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD): Phase 3, Randomized, Double-Blind, Multicenter, Placebo- and Active-Reference Study

Published online by Cambridge University Press:  15 April 2020

A. Hervas ,
M. Huss ,
M. Johnson ,
F. McNicholas ,
J. Van Stralen ,
S. Sreckovic ,
A. Lyne ,
R. Bloomfield ,
V. Sikirica  and
B. Robertson
A. Hervas
Affiliation:
Child and Adolescent Mental Health Unit, University Hospital Mútua de Terrassa, Barcelona, Spain
M. Huss
Affiliation:
Child and Adolescent Psychiatry, Johannes Gutenberg-University Mainz, Mainz, Germany
M. Johnson
Affiliation:
The Gillberg Neuropsychiatry Centre at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
F. McNicholas
Affiliation:
Department of Child and Adolescent Psychiatry, Our Lady's Children's Hospital, Dublin, Ireland
J. Van Stralen
Affiliation:
JPM van Stralen Medicine Professional Corporation, Center for Pediatric Excellence, Ottawa, Canada
S. Sreckovic
Affiliation:
N/A, Shire, Eysins, Switzerland
A. Lyne
Affiliation:
N/A, Shire, Basingstoke, United Kingdom
R. Bloomfield
Affiliation:
N/A, Shire, Basingstoke, United Kingdom
V. Sikirica
Affiliation:
N/A, Shire, Wayne, USA
B. Robertson
Affiliation:
N/A, Shire, Wayne, USA

Abstract

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Introduction:

GXR, a selective α2A-adrenergic agonist, is a non-stimulant treatment for ADHD (approved in the USA for children and adolescents and in Canada for children).

Objectives:

To assess the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD.

Aims:

To evaluate the efficacy (symptom and function) and safety of GXR for the treatment of ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo (NCT01244490).

Methods:

Patients (6–17 years) were randomly assigned at baseline to dose-optimized GXR (6–12 years, 1–4 mg/day; 13–17 years, 1–7 mg/day), ATX (10–100mg/day) or placebo for 4 or 7 weeks. The primary efficacy measure is change from baseline in ADHD-Rating Scale-version IV (ADHD-RS-IV). Key secondary measures were defined as Clinical Global Impressions-Improvement (CGI-I) and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P). Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs.

Results:

Of 338 patients randomized, 272 (80.5%) completed the study. Placebo-adjusted differences in least squares (LS) mean in ADHD-RS-IV total score, percent improvement versus placebo for CGI-I, placebo-adjusted differences in LS mean change from baseline in WFIRS-P score (family and learning and school domains) are shown in the Table. The most common TEAEs for GXR were somnolence, headache, and fatigue; 8 (7%) TEAEs were severe.

Conclusions:

GXR was effective and well tolerated in children and adolescents with ADHD.

 GXRATX
Placebo-adjusted difference in LS mean change from baseline in ADHD-RS-IV total score (95% Cl, p-value; effect size)−8.9 (−11.9, −5.8, p<0.001; 0.76)−3.8 (−6.8, −0.7, p<0.05; 0.32)
Difference in improvement from placebo for CGI-I (95% Cl, p-value)23.7% (11.1, 36.4; p<0.001)12.1% (−0.9, 25.1; p<0.05)
Placebo-adjusted difference in LS mean change from baseline in WFIRS-P; learning and school domain score (95%CI, p-value; effect size)−0.22 (−0.36, −0.08, p<0.01; 0.42)−0.16 (−0.31, −0.02, p<0.05; 0.32)
Placebo-adjusted difference in LS mean change from baseline in WFIRS-P; family domain score (95%CI, p-value; effect size)−0.21 (−0.36, −0.06, p<0.01; 0.38)−0.09 (−0.24, 0.06, p=0.242; 0.16)

Type
E06 – e-Poster Oral Session 06: Child Psychiatry and Personality Disorders
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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