Neurocrine Biosciences, Inc. NBIX announced today that it has initiated a clinical trial of NBI-98854, a
proprietary small molecule Vesicular Monoamine Transporter 2 (VMAT2)
inhibitor, in both children and adolescents with Tourette syndrome.
The T-Force study is an open-label, multi-dose, two-week study of 36 subjects
with Tourette syndrome. Children and adolescents will receive once-daily
dosing of NBI-98854 during a two-week treatment period to assess both the
safety and tolerability of NBI-98854 in Tourette patients. Additionally, the
Yale Global Tic Severity Scale and the Premonitory Urge for Tics Scale will be
employed during the study to assess the impact of NBI-98854 on the patients'
Tourette symptoms. Data readout from this study is expected in 2015.
"Advancing NBI-98854 into clinical evaluation of Tourette syndrome represents
another significant achievement for our VMAT2 franchise," said Kevin C.
Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "An
important aspect of this initial Tourette syndrome trial is that we are
exploring NBI-98854 in children age six to eleven, the target age range for
therapy."
T-Force Study Design
The T-Force study is an open-label, multiple ascending dose, pharmacokinetic
and pharmacodynamic, study to evaluate the safety, tolerability and
exposure-response of NBI-98854 in children and adolescents with Tourette
syndrome. A total of 36 patients will be evaluated over 14 days of once-daily
dosing followed by 7 days off-drug at approximately 10 study centers in the
United States. The study will be divided into two dosing groups consisting of
children (ages 6-11) and adolescents (ages 12-18), and each age group will be
further divided into three dosing cohorts of six patients each. After
completing the initial two weeks of dosing with the first adolescent cohort,
an independent review of both safety and pharmacokinetic results will occur
prior to escalating the dose level for the second cohort of adolescents. In
parallel, while initiating the second cohort of adolescents, the first cohort
of children (ages 6-11) will also be administered NBI-98854 for a two-week
period. Subsequent dose escalations for children and adolescents will be
based, in part, on the pharmacokinetic and safety data from the previous
cohort in each age group. Additionally, the patient's Tourette symptoms will
be evaluated weekly via the Yale Global Tic Severity Scale, the Premonitory
Urge for Tics Scale as well as an overall Clinical Global Impression in
Tourette syndrome Scale.
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