Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder.
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).


METHODS
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.
R/D Clinical Research Inc., 461 This Way, Lake Jackson, TX 77566, USA. drjain_research@hotmail.com
Rakesh
R
Jain
Scott
S
Segal
Scott H
SH
Kollins
Moise
M
Khayrallah
D000293:Adolescent; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003000:Clonidine / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male
D058647:Adrenergic alpha-2 Receptor Agonists; D003692:Delayed-Action Preparations; D003000:Clonidine