Nuvelution Pharma has started enrolling patients in a Phase II/III trial of Austedo (deutetrabenazine) for the treatment of tics associated with Tourette's syndrome.
Tourette's syndrome is a neurological disorder characterised by repetitive, stereotyped, involuntary movements and vocalisations known as tics. The disease can be a chronic condition and its early symptoms are typically observed first in childhood.
The multicentre, randomised, double-blind, placebo-controlled Phase II/III ARTISTS1 study has been designed to evaluate the safety, tolerability, and efficacy of Austedo (deutetrabenazine).
It will enrol up to 100 pediatric patients with moderate to severe Tourette's syndrome.
As part of the trial, patients will be given either Austedoor placebo using a 1:1 randomisation over 12 weeks of dosing.
ARTISTS 1’s primary objective is the change in the total tic score (TTS) of the Yale global tic severity scale (YGTSS) from baseline to week 12 between placebo and active treatment groups.
Tourette's symptoms will also be analysed using clinical and patient global impression scales under the trial.
For conducting the trial, Nuvelution has signed a partnership agreement with Teva in September last year. The companies will work together for the corresponding regulatory submissions.
In April last year, Nuvelution received approvals from the US Food and Drug Administration (FDA) to use Austedo for the treatment of chorea associated with Huntington’s disease and for tardive dyskinesia in adults.
Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor, and has also received orphan drug designation from FDA for the treatment of Tourette's in the pediatric population.