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EPA-0666 – Long-term Maintenance of Efficacy of Extended-Release Guanfacine Hydrochloride (GXR) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD): Double-Blind, Placebo-Controlled, Multicentre, Phase 3 Randomized Withdrawal Study

Published online by Cambridge University Press:  15 April 2020

J. Newcorn ,
V. Harpin ,
M. Huss ,
M. Johnson ,
J.A. Ramos-Quiroga ,
J. Van Stralen ,
B. Dutray ,
S. Sreckovic ,
A. Lyne  and
R. Bloomfield
...Show all authors
J. Newcorn
Affiliation:
Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, USA
V. Harpin
Affiliation:
Ryegate Children's Centre, Sheffield, United Kingdom
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
J.A. Ramos-Quiroga
Affiliation:
Department of Psychiatry, Hospital Universtari Vall d’Hebron, Barcelona, Spain
J. Van Stralen
Affiliation:
JPM van Stralen Medicine Professional Corporation, Center for Pediatric Excellence, Ottawa, Canada
B. Dutray
Affiliation:
Pôle de Psychiatrie Enfant Adolescent, Centre Hospitalier de Rouffach, Rouffach, France
S. Sreckovic
Affiliation:
Shire, Eysins, Switzerland
A. Lyne
Affiliation:
Shire, Basingstoke, United Kingdom
R. Bloomfield
Affiliation:
Shire, Basingstoke, United Kingdom
B. Robertson
Affiliation:
Shire, Wayne, USA

Abstract

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Introduction:

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

Objectives:

To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial.

Aims:

To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145).

Methods:

Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimization and 6-week maintenance periods on open-label GXR (1–7 mg/day), eligible patients entered a 26-week, double-blind, RWP with GXR or placebo. The primary endpoint was rate of treatment failure (≥50% increase in ADHD-RS-IV total score and ≥2-point increase in CGI-S at two consecutive visits, compared to the RWP baseline). The key secondary endpoint was time-to-treatment failure. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms and vital signs.

Results:

Of 528 patients enrolled, 316 (60.0%) entered the RWP. At study end, 49.3% (GXR) and 64.9% (placebo) (95%CI; −26.6, −4.5, p<0.01) of patients had relapsed (Figure). Time-to-treatment failure was 56 days (placebo) versus 218 days (GXR), p=0.003. During the RWP, the most common GXR TEAEs (≥5% patients) were headache, somnolence and nasopharyngitis.

Conclusions:

GXR demonstrated long-term maintenance of efficacy versus placebo in children and adolescents with ADHD.

Type
EPW37 – Psychopharmacology and Pharmacoeconomics 2
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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