US-based biotechnology firm Neurocrine Biosciences has started a Phase IIb clinical trial (T-Force GOLD) of Ingrezza (valbenazine) for the treatment of children and adolescents with Tourette syndrome.
Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated as a capsule formulation for treating adults with tardive dyskinesia in the US.
Reportedly, the investigational candidate does not have significant binding affinity for VMAT1, dopaminergic, serotonergic, adrenergic, histaminergic or muscarinic receptors.
The multi-centre, randomised, double-blind, placebo-controlled, parallel group Phase IIb trial is designed to evaluate the safety, tolerability, efficacy and optimal dose of once-a-day Ingrezza.
Up to 120 subjects with moderate to severe disease will be administered with Ingrezza or placebo for 12 weeks, followed by two weeks off-drug period.
Neurocrine Biosciences chief medical officer Christopher O'Brien said: "We are committed to continuing studies of Ingrezza in patients with neurological disorders including paediatric patients with Tourette syndrome.
“We have gained valuable insights from our previous studies of Ingrezza in patients with Tourette syndrome and look forward to continuing to advance this programme to further assess Ingrezza as a potential treatment option for paediatric Tourette patients."
The T-Force GOLD trial’s primary endpoint is change of the Yale Global Tic Severity Scale from baseline to end of week 12 between active and placebo arms.
During the trial, disease symptoms will be assessed using the Premonitory Urge for Tics and Clinical Global Impression Scales.
Neurocrine expects that the top-line results from the Phase IIb trial will be available late next year.