Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
This is a two-part, randomized, multi-center, blinded study in adolescents with Tourette's
Disorder. There will be an up to 21-day screening period in which subject eligibility will be
determined. In Part 1 of the study, the safety, tolerability and pharmacokinetics of AZD5213
will be assessed during a 1- week period.
In Part 2 of the study, the safety, tolerability, and preliminary efficacy of two doses
(depending on tolerability in Part 1 of the study) of AZD5213 and placebo will be assessed
through six consecutive four-week crossover periods. Each subject will receive both AZD5213
and placebo. A follow-up vist will take place at 14 (±) 7 days following the last dose of
study drug.