OBJECTIVE: This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHOD: This 8-week, placebo-controlled, fixed-dose trial, including 3 weeks of dose escalation, of patients 6 to 17 years old with ADHD evaluated the efficacy and safety of CLON-XR 0.2 mg/day or CLON-XR 0.4 mg/day versus placebo in three separate treatment arms. Primary endpoint was mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to week 5 versus placebo using a last observation carried forward method. Secondary endpoints were improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Severity, Clinical Global Impression of Improvement, and Parent Global Assessment from baseline to week 5. RESULTS:Patients (N = 236) were randomized to receive placebo (n = 78), CLON-XR 0.2 mg/day (n = 78), or CLON-XR 0.4 mg/day (n = 80). Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5. A significant improvement in ADHD-RS-IV total score occurred between groups as soon as week 2 and was maintained throughout the treatment period. In addition, improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Improvement, Clinical Global Impression of Severity, and Parent Global Assessment, occurred in both treatment groups versus placebo. The most common treatment-emergent adverse event was mild-to-moderate somnolence. Changes on electrocardiogram were minor and reflected the known pharmacology of clonidine. CONCLUSIONS:Clonidine hydrochloride extended-release tablets were generally well tolerated by patients in the study and significantly improved ADHD symptoms in this pediatric population.
RCT Entities:
OBJECTIVE: This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHOD: This 8-week, placebo-controlled, fixed-dose trial, including 3 weeks of dose escalation, of patients 6 to 17 years old with ADHD evaluated the efficacy and safety of CLON-XR 0.2 mg/day or CLON-XR 0.4 mg/day versus placebo in three separate treatment arms. Primary endpoint was mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to week 5 versus placebo using a last observation carried forward method. Secondary endpoints were improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Severity, Clinical Global Impression of Improvement, and Parent Global Assessment from baseline to week 5. RESULTS:Patients (N = 236) were randomized to receive placebo (n = 78), CLON-XR 0.2 mg/day (n = 78), or CLON-XR 0.4 mg/day (n = 80). Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5. A significant improvement in ADHD-RS-IV total score occurred between groups as soon as week 2 and was maintained throughout the treatment period. In addition, improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Improvement, Clinical Global Impression of Severity, and Parent Global Assessment, occurred in both treatment groups versus placebo. The most common treatment-emergent adverse event was mild-to-moderate somnolence. Changes on electrocardiogram were minor and reflected the known pharmacology of clonidine. CONCLUSIONS:Clonidine hydrochloride extended-release tablets were generally well tolerated by patients in the study and significantly improved ADHD symptoms in this pediatric population.
Authors: Mark Wolraich; Lawrence Brown; Ronald T Brown; George DuPaul; Marian Earls; Heidi M Feldman; Theodore G Ganiats; Beth Kaplanek; Bruce Meyer; James Perrin; Karen Pierce; Michael Reiff; Martin T Stein; Susanna Visser Journal: Pediatrics Date: 2011-10-16 Impact factor: 7.124
Authors: Hanna Kovshoff; May Vrijens; Margaret Thompson; Lucy Yardley; Paul Hodgkins; Edmund J S Sonuga-Barke; Marina Danckaerts Journal: Eur Child Adolesc Psychiatry Date: 2013-03-02 Impact factor: 4.785
Authors: Mark L Wolraich; Joseph F Hagan; Carla Allan; Eugenia Chan; Dale Davison; Marian Earls; Steven W Evans; Susan K Flinn; Tanya Froehlich; Jennifer Frost; Joseph R Holbrook; Christoph Ulrich Lehmann; Herschel Robert Lessin; Kymika Okechukwu; Karen L Pierce; Jonathan D Winner; William Zurhellen Journal: Pediatrics Date: 2019-10 Impact factor: 7.124
Authors: Catherine A Martin; Paul A Nuzzo; John D Ranseen; Mark S Kleven; Greg Guenthner; Yolanda Williams; Sharon L Walsh; Linda P Dwoskin Journal: J Atten Disord Date: 2013-08-21 Impact factor: 3.256