The Efficacy and Tolerability of the Clonidine Transdermal Patch in the Treatment for Children with Tic Disorders: A Prospective, Open, Single-Group, Self-Controlled Study

Abstract

BackgroundTo evaluate the efficacy and tolerability of a clonidine transdermal patch in the treatment of children with tic disorders (TD) and to establish a predictive model for patients.MethodsForty-one patients who met the inclusion criteria entered into 12 weeks of prospective, open, single-group, self-controlled treatment with a clonidine transdermal patch. The Yale Global Tic Severity Scale (YGTSS) was employed before therapy (baseline) and at 4, 8, and 12 weeks after therapy.Results(1) The total effect rates of treatment with a clonidine transdermal patch were 29.27, 53.66, and 63.41% at 4, 8, and 12 weeks, respectively. Compared with the baseline, the differences were significant at three different observation periods. (2) Compared to the level of 25% reduction, there were significant decreases in the score-reducing rate of motor tic and total tic severities at 12 weeks. (3) If the disease course was ≤24 months and the motor tic score was <16 at the baseline, there was an effective rate of 100% for treatment with the clonidine transdermal patch. If the disease course was ≤24 months and the motor tic score was >16, there was an effective rate of 57.1%. If the disease course was >24 months and the clinical classification was chronic TD, there was an effective rate of 62.5%. If the disease course was >24 months and the clinical classification was Tourette’s syndrome, 90% of the patients were invalid. (4) The main adverse events were rash, slight dizziness, and headache.Conclusion(1) When patients were pretreated with a D2-dopamine receptor antagonist that was ineffective or not tolerated well, switching to a clonidine transdermal patch treatment was effective and safe. (2) A clonidine transdermal patch could be a first-line medication for mild and moderate TD cases that are characterized by motor tics.

A Review of the Current Treatment of Tourette Syndrome

“…21 It is thought to reduce tics through the resultant decrease of norepinephrine release and turnover. 22 Clonidine offers a therapeutic option without the risks of drug-induced movement disorders that can be associated with antipsychotic drugs. However, evidence supporting the efficacy of clonidine is inconsistent and is often based on small numbers of patients.…”

“…The YGTSS is a widely used, semi-structured and clinician-rated measure of the severity of tic characteristics, including the number, frequency, intensity, complexity, and their interference with lifestyle. 5,22 YGTSS total scores combine the measured effect on motor tic, vocal tic, and overall improvements. In addition, changes in Clinical Global Impression rating scale scores (CGI), which provide a separate improvement rating and a summation of YGTSS subscores, were also reported.…”

“…Clonidine patches pose an attractive alternative to oral treatment, with the potential for reduced sedation due to more consistent blood levels and possible improved compliance compared with multiple daily dosing. 22 In a randomized, double-blind, multicenter placebo-controlled trial, Du et al 24 studied the effectiveness and safety of clonidine patches on tic reduction. The study included 437 patients (aged 6-18 years) with chronic motor or vocal tic disorders (40%), transient tic disorder (5%), or Tourette disorder (55%).…”

Tourette Syndrome Treatment Updates: a Review and Discussion of the Current and Upcoming Literature

“…Although early studies of the effectiveness of clonidine were mixed [58], clonidine has been shown to be more effective than placebo at reducing tics [59] and additionally helps improve tics in patients with comorbid TS and ADHD [60]. The clonidine adhesive patch has additionally been shown to be safe and effective for TS management [61][62][63] and is comparable to haloperidol [64][65][66]. Guanfacine has had mixed results with some studies demonstrating safety and efficacy [67,68], but others not demonstrating significant tic reduction [69,70].…”

Efficacy of Behavioural Intervention, Antipsychotics, and Alpha Agonists in the Treatment of Tics Disorder in Tourette’s Syndrome

“…As far as pharmacological therapy is concerned, clonidine, an alpha agonist, is useful in treating Tourette's syndrome. Clonidine transdermal patch has no peak plasma concentration, which is used continuously for a week to have maximum efficacy and fewer side effects [ 10 ]. Antipsychotics such as aripiprazole improve tics in patients suffering from TS with OCD [ 11 ].…”