title: A placebo-controlled study of lofexidine in the treatment of children with tic disorders and attention deficit hyperactivity disorder.
abstract: This study evaluated the efficacy and safety of Lofexidine in treating children with tic disorders and attention deficit hyperactivity disorder (ADHD). Subjects from a specialty tic disorders clinic were randomly assigned to receive 8 weeks of treatment with lofexidine or placebo under double-blind conditions. Follow-up visits occurred every 2 weeks for safety monitoring and dose adjustment. Fourty-four medication-free subjects (41 boys and three girls; mean age of 10.4 years) with ADHD, combined type, and a tic disorder participated. After 8 weeks of treatment, lofexidine was associated with a mean improvement of 41% in the total score on the teacher-rated ADHD Rating Scale compared to 7% improvement for placebo. Eleven of 22 subjects who received lofexidine were blindly rated on the Clinical Global Scale-Improvement as either much improved or very much improved compared to none of 22 subjects who received placebo. The mean score on the parent-rated hyperactivity index improved by 29% in the lofexidine group and 18% in the placebo group, which was not a significant difference. On the Continuous Performance Test, commission errors decreased by 25% and omission errors by 20% in the lofexidine group, compared with increases of 33% in commission errors and of 36% in omission errors in the placebo group. Tic severity decreased by 27% in the lofexidine group, compared to 0% in the placebo group. One lofexidine subject with sedation withdrew at week 4. Lofexidine was associated with insignificant decreases in blood pressure and pulse. Lofexidine appears to be a safe and effective treatment for children with tic disorders and ADHD.
authors.affiliation: Christian Doppler Klinik, Department of Neurology, Salzburg, Austria. helmut.niederhofer@uibk.ac.at
authors.forename: Helmut
authors.initials: H
authors.lastname: Niederhofer
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Staffen
authors.forename: Alois
authors.initials: A
authors.lastname: Mair
mesh_terms: D000293:Adolescent; D000322:Adrenergic Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D003000:Clonidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D009483:Neuropsychological Tests; D013981:Tic Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000322:Adrenergic Agonists; D003000:Clonidine; C025655:lofexidine