Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome

Abstract

IMPORTANCETourette syndrome is a neurodevelopmental disorder characterized by childhood onset of motor and phonic tics; treatments for tics are associated with safety concerns. Deutetrabenazine is a selective vesicular monoamine transporter 2 inhibitor approved for the treatment of chorea associated with Huntington disease and tardive dyskinesia in adults. OBJECTIVE To examine whether deutetrabenazine is effective and safe for the treatment of Tourette syndrome in children and adolescents. DESIGN, SETTING, AND PARTICIPANTS This phase 2/3, randomized, double-masked, placebocontrolled, parallel-group, dose-titration study included children and adolescents (aged 6-16 years) with Tourette syndrome with active tics causing distress or impairment (ie, Yale Global Tic Severity Scale-Total Tic Score [YGTSS-TTS] Ն20). The trial was conducted over 12 weeks, with 1 week of

Tourette syndrome research highlights from 2021

“…To date, the mother compound, tetrabenazine, has been used largely off label for tic treatment in the absence of evidence derived from high quality clinical studies. Alas, both deutetrabenazine 90 , 91 and valbenazine failed to meet primary endpoints in their respective studies. 92 …”

“…To date, the mother compound, tetrabenazine, has been used largely off label for tic treatment in the absence of evidence derived from high quality clinical studies. Alas, both deutetrabenazine 90,91 and valbenazine failed to meet primary endpoints in their respective studies. 92 An interesting case series described six children or adolescents with aggressive behaviors in whom lurasidone, a novel antipsychotic, was added to either aripiprazole or risperidone; the addition of lurasidone appeared to diminish these symptoms with good tolerability.…”

Emerging therapies and recent advances for Tourette syndrome

“…There was no significant change in YGTSS-TTS ( p = 0.690) from baseline at the end of 12 weeks. Thus the study did not meet its primary endpoint [ 61 ]. No serious adverse events were reported and the most common TEAEs were fatigue, weight increase, and headache [ 61 ].…”

“…Thus the study did not meet its primary endpoint [ 61 ]. No serious adverse events were reported and the most common TEAEs were fatigue, weight increase, and headache [ 61 ].…”

Efficacy and safety of Jiu-Wei-Xi-Feng granules for treating tic disorders in children: study protocol for a randomized controlled equivalence trial

“…There are many internationally registered clinical trials on TD in children, most of which are chemical drugs. The overall design of clinical trial control for new drugs such as first-line therapeutic drugs such as aripiprazole and benzoxazines witch is under development is placebo as a control, and the superiority test is used to prove its effectiveness and safety [14,15]. The clinical trials of new traditional Chinese medicine for children's TD have gradually matured.…”