Neurocrine Biosciences has initiated a Phase IIb clinical trial, T-Force GOLD, for INGREZZA (valbenazine), a novel selective vesicular monoamine transporter 2 (VMAT2) inhibitor, in children and adolescents with Tourette syndrome. Tourette syndrome is a neurological disorder that becomes evident in early childhood or adolescence and is characterized by motor and vocal tics.
"We are committed to continuing studies of INGREZZA in patients with neurological disorders including pediatric patients with Tourette syndrome," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "We have gained valuable insights from our previous studies of INGREZZA in patients with Tourette syndrome and look forward to continuing to advance this program to further assess INGREZZA as a potential treatment option for pediatric Tourette patients."
INGREZZA capsules are marketed in the United States for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.
The T-Force GOLD study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase IIb study to evaluate the safety, tolerability, efficacy and optimal dose of once-daily INGREZZA in up to 120 pediatric patients with moderate to severe Tourette syndrome. Patients will receive either once-daily dosing of INGREZZA or placebo using a 1:1 randomization over 12 weeks of dosing followed by two weeks off-drug. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week 12. Tourette symptoms will also be evaluated via the Premonitory Urge for Tics Scale as well as Clinical Global Impression Scales. Top-line data from this study is expected in late 2018.
Tourette syndrome is a neurological disorder that consists of rapid, non-rhythmic stereotyped motor and vocal tics. Motor tics are typically characterized by facial grimacing, head jerks, extremity movements and other stereotyped movements. Vocal tics typically include grunting, throat clearing, and repeating words and phrases. The average age of onset for Tourette syndrome is six years, with symptoms reaching their peak severity at approximately age ten. Tourette syndrome is more commonly diagnosed in males than females and may be associated with attention deficit hyperactivity disorder and obsessive-compulsive disorder.