TY - JOUR
T1 - Double-Blind, Crossover Study of Clonidine and Levetiracetam in Tourette Syndrome
AU - Hedderick, Erika F.
AU - Morris, Christina M.
AU - Singer, Harvey S.
N1 - Funding Information:
This study was partially funded by UCB Pharmaceuticals.
Funding Information:
Subjects aged 8-30 years with Tourette syndrome were enrolled from the Tourette Syndrome Clinic at Johns Hopkins Hospital, a university referral-based clinic. A diagnosis of Tourette syndrome was defined according to the Tourette Syndrome Classification Study Group [15] . All had moderate to moderately severe tics, confirmed by a minimum score of 22 on the Total Tic Score of the Yale Global Tic Severity Scale. Patients were excluded if they had secondary tics, current major depression, untreated generalized anxiety disorder, separation anxiety disorder, psychotic signs (based on clinical evaluation), pervasive developmental disorder, autism, mental retardation (intelligence quotient, <70), anorexia/bulimia, or substance abuse. Subjects with comorbid attention deficit hyperactivity disorder, obsessive—compulsive disorder, and conduct disorder were not excluded. This study was approved by the Johns Hopkins Institutional Review Board and was partially funded by UCB Pharmaceuticals (Brussels, Belgium), the manufacturer of levetiracetam.
PY - 2009/6
Y1 - 2009/6
N2 - We compared the efficacy of clonidine and levetiracetam for treating tics in Tourette syndrome. Twelve subjects were enrolled; 10 (ages 8-27 years) with moderate to moderately severe tics completed a 15-week randomized, double-blind, flexible-dose crossover protocol. Initial medication doses were clonidine (0.05 mg, twice daily) or levetiracetam (10 mg/kg/day, divided twice daily). Doses were adjusted weekly, based on telephone assessment. The primary outcome measure was baseline-to-posttreatment (6-week) change in Total Tic Score of the Yale Global Tic Severity Scale. Secondary outcome measures included total Yale Global Tic Severity Scale and Clinical Global Impression scores and behavioral measures. The mean Total Tic Score improved significantly from baseline to posttreatment with clonidine (25.2 versus 21.8) compared with levetiracetam (22.7 versus 23.6) (P = 0.013). The mean total Yale Global Tic Severity Scale and Clinical Global Impression score did not change. For levetiracetam, no changes occurred in any scales. No significant change occurred in any secondary behavioral outcome measures for either group. The most commonly reported side effects were, for clonidine, sedation (n = 5), and for levetiracetam, irritability (n = 4). Treatment with clonidine, but not levetiracetam, resulted in a small reduction in Total Tic Score, with an effect size of 0.57.
AB - We compared the efficacy of clonidine and levetiracetam for treating tics in Tourette syndrome. Twelve subjects were enrolled; 10 (ages 8-27 years) with moderate to moderately severe tics completed a 15-week randomized, double-blind, flexible-dose crossover protocol. Initial medication doses were clonidine (0.05 mg, twice daily) or levetiracetam (10 mg/kg/day, divided twice daily). Doses were adjusted weekly, based on telephone assessment. The primary outcome measure was baseline-to-posttreatment (6-week) change in Total Tic Score of the Yale Global Tic Severity Scale. Secondary outcome measures included total Yale Global Tic Severity Scale and Clinical Global Impression scores and behavioral measures. The mean Total Tic Score improved significantly from baseline to posttreatment with clonidine (25.2 versus 21.8) compared with levetiracetam (22.7 versus 23.6) (P = 0.013). The mean total Yale Global Tic Severity Scale and Clinical Global Impression score did not change. For levetiracetam, no changes occurred in any scales. No significant change occurred in any secondary behavioral outcome measures for either group. The most commonly reported side effects were, for clonidine, sedation (n = 5), and for levetiracetam, irritability (n = 4). Treatment with clonidine, but not levetiracetam, resulted in a small reduction in Total Tic Score, with an effect size of 0.57.
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U2 - 10.1016/j.pediatrneurol.2008.12.014
DO - 10.1016/j.pediatrneurol.2008.12.014
M3 - Article
C2 - 19433274
AN - SCOPUS:65449137478
SN - 0887-8994
VL - 40
SP - 420
EP - 425
JO - Pediatric Neurology
JF - Pediatric Neurology
IS - 6
ER -