Randomized, double-blind trial of guanfacine extended release in children with attention-deficit/hyperactivity
Jeffrey H Newcorn1, Mark A Stein, Ann C Childress
1Icahn School of Medicine at Mount Sinai. jeffrey.newcorn@mssm.edu
Insights
Guanfacine extended release (GXR) significantly improved ADHD symptoms in children, with similar efficacy and tolerability whether taken in the morning or evening. This study highlights GXR as an effective once-daily treatment option for pediatric ADHD.
Area of Science:
- Pediatric Neurology
- Pharmacology
- Child Psychiatry
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Effective and tolerable treatment options are crucial for managing ADHD symptoms.
Purpose of the Study:
- To evaluate the efficacy and tolerability of guanfacine extended release (GXR) in children with ADHD.
- To compare morning versus evening administration of GXR.
Main Methods:
- A multicenter, double-blind, placebo-controlled study involving 333 children aged 6-12 with ADHD.
- Participants were randomized to receive GXR in the morning, GXR in the evening, or placebo twice daily.
- The ADHD Rating Scale-IV (ADHD-RS-IV) was used as the primary efficacy measure.
Main Results:
- Both morning and evening GXR administration showed significant improvements in ADHD-RS-IV total scores compared to placebo (p < .001).
- Mean changes from baseline were -19.8 for GXR am, -20.1 for GXR pm, and -11.0 for placebo.
- The most common treatment-emergent adverse event was somnolence, reported by 46.7% in the GXR am group and 42.1% in the GXR pm group, versus 12.5% in the placebo group.
Conclusions:
- Once-daily GXR monotherapy is effective and well-tolerated in children with ADHD, regardless of whether it is administered in the morning or evening.
- GXR provides significant and clinically meaningful improvements in ADHD symptoms.
- The dosing time (morning vs. evening) did not impact the overall response or tolerability of GXR.
Objective:
To examine the efficacy and tolerability of guanfacine extended release (GXR) administered in the morning or evening in children with attention-deficit/hyperactivity disorder (ADHD).
Method:
In this multicenter, double-blind, placebo-controlled, dose-optimization study, children 6 to 12 years of age with ADHD were randomized to receive GXR (1-4 mg/d) in the morning and placebo in the evening (GXR am), placebo in the morning and GXR in the evening (GXR pm), or twice-daily placebo. The primary efficacy measure was the ADHD Rating Scale-IV (ADHD-RS-IV).
Results:
A total of 333 child participants received study drug in the following cohorts: GXR am (n = 107), GXR pm (n = 114), or placebo (n = 112). Mean (standard deviation) changes from baseline to week 8 (visit 10 or last observation carried forward) in ADHD-RS-IV total scores were significant for both GXR treatment groups combined (GXR all-active: -20.0 [12.97]) and separately (GXR am: -19.8 [12.95]; GXR pm: -20.1 [13.04]) compared with placebo (-11.0 [12.93]; p < .001 for all). Most spontaneously-elicited treatment-emergent adverse events were mild or moderate in severity; the most common was somnolence (GXR all-active: 44.3%; GXR am: 46.7%; GXR pm: 42.1%; placebo: 12.5%).
Conclusions:
GXR administered either in the morning or evening was associated with significant and clinically meaningful improvements in ADHD symptoms. The levels of response and tolerability observed with GXR were similar regardless of time of dosing (morning versus evening), indicating that once-daily GXR monotherapy is effective whether administered in the morning or evening. Clinical trial registration information-Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study.
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