Clonidine Extended-Release Tablets for Pediatric Patients With Attention-Deficit/Hyperactivity Disorder - 10/08/11
, Scott Segal, M.D. c, Scott H. Kollins, Ph.D. d, Moise Khayrallah, Ph.D. e
Correspondence to Rakesh Jain, M.D., M.P.H., R/D Clinical Research, Inc., 461 This Way, Lake Jackson, TX 77566Résumé |
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. Clinical trials registry information—Study Evaluating the Safety and Efficacy of Clonicel to Treat Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD), URL: www.clinicaltrials.gov, unique identifier: NCT00556959.
Le texte complet de cet article est disponible en PDF.Key Words : ⍺2-adrenergic agonist, attention-deficit/hyperactivity disorder, clonidine hydrochloride extended-release tablets
Plan
| This article can be used to obtain continuing medical education (CME) category 1 credit at jaacap.org. |
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| This study was supported by Addrenex Pharmaceuticals, Inc., a Shionogi company. |
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| Writing and editorial assistance was provided under the direction of Dr. Jain by Jillian Gee, Ph.D., of MedThink Communications with support from Shionogi Inc. Statistical analyses were performed by Greg Ginn and Natalie Walker of Stat-Tech Services, LLC. The authors thank Drs. Nicole Forman and Chao Wang, Shionogi Inc., for their assistance with analysis of the clinical trial data and critical review of the report. |
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| Disclosure: Dr. Jain has served as a consultant to, on the advisory board for, and has provided research support to Shionogi and Addrenex. Dr. Kollins has received research support and/or served as a consultant for Addrenex, Otsuka, Shire, the National Institute on Drug Abuse, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, and the Environmental Protection Agency. Dr. Khayrallah was an employee and shareholder of Addrenex Pharmaceuticals, Inc., a Shionogi company, Durham, NC, at the time of the study. Dr. Segal reports no biomedical financial interests or potential conflicts of interest. |
Vol 50 - N° 2
P. 171-179 - février 2011 Retour au numéro
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