Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and
pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome
(TS). The study will be conducted in approximately 18 male and female children (6 to 11 years
of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age
groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses
will be evaluated as part of a staggered-cohort design. Study drug will be administered in
each cohort for 14 consecutive days.