Effectiveness and Safety of a Clonidine Adhesive Patch for Children With Tic Disorders: Study in a Real-World Practice

Background: Real-world evidence includes data from retrospective/prospective observational studies and observational registries, and provides insights beyond those addressed by randomized controlled trials. This study aimed to evaluate the effectiveness and safety of a clonidine adhesive patch (CAP) for children with tic disorder (TD) in a real-world setting (RWS). Methods: This was an open-label, non-interventional, post-marketing, observational study in a RWS. Children diagnosed with TDs were enrolled from a pediatric neurology clinic in China, and the change in tic symptom severity following 6 weeks pharmacologic treatments was investigated using Yale Global Tic Severity Scale (YGTSS) during visits at weeks 0, 4, 8, and 12. Results: Of 150 patients, 76% (114/150) were male (age range, 3.03-14.24 years; mean, 8.11 +/- 2.48 years). Patients were divided into three groups: tiapride (n = 94), CAP (n = 14), and CAP + tiapride (n = 42). The mean YGTSS improved 11.02, 15.14, 11.13 points from baseline to posttreatment for tiapride, CAP, and CAP + tiapride, respectively, but variance analysis showed there was no significant difference in YGTSS related to different pharmacologic intervention during subsequent visits at weeks 4, 8, and 12. Repeated measure analysis showed there was no significant difference between different medication types for reducing the YGTSS score (F = 0.553, P = 0.576). No serious adverse events (AEs) occurred, and there was no significant difference in the prevalence of AEs between the three groups. Conclusion: The CAP is effective and safe for TD management in a RWS, because of the limitation of sample size and the period of follow up, observational studies with longer-term outcomes, and larger sample size are needed.