Tourette Syndrome Clinical Trial
Official title:
A 6-month, Multicenter, Randomized, Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
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.
This is a multicenter, randomized, two-part study of AZD5213 in adolescents (ages 12-17
years) with Tourette's Disorder.
In Part 1 of the study, following an up to 21-day screening period, on Day 1, after baseline
procedures are performed, eligible subjects will receive a single, low dose of AZD5213,
in-clinic.
After study drug dosing on Day 1, safety and tolerability will be assessed in-clinic, and
blood samples will be taken for pharmacokinetic (PK) analysis. On Days 2, 3, 4, 5, 6 and 7
subjects will take study drug, and will be contacted via telephone and adverse events and
concomitant medications will be assessed. On Day 8, safety, tolerability, and blood sampling
for PK analysis (predose and 2-4 hours post-dose) will be performed in-clinic. Part 2 of the
study will consist of six consecutive crossover periods. In Part 2 of the study, each study
drug will be administered in two 4-week periods (six treatment periods, total). Each study
drug will be received in one of Periods 1-3, and again in one of Periods 4-6. Approximately
24 subjects will receive study drug in Part 1 of this study in order to complete
approximately 18 subjects in Part 2.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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