A 6-Month, Multicenter, Randomized, Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of AZD5213 in Adolescents with Tourette’s Disorder (TD)

Principal Investigator: Barbara Coffey, MD, MS

Sponsor: AstraZeneca

Overview: This is a two-part, randomized, multi-center, blinded study that is designed to assess the safety, tolerability, and preliminary efficacy of AZD5213 in adolescents with Tourette’s disorder (TD).

Inclusion Criteria

  • Male of female between the ages of 12 and 17
  • Diagnosis of TD
  • Symptoms of TD must impair school, occupational, and/or social function

Exclusion Criteria

  • Prior participation in any AZD5213 study
  • Inability to swallow study drug capsules
  • Significant fear of needles and/or blood draw, or unsatisfactory venous access
  • Acute suicidality or history of suicidal behavior
  • History of seizure disorder other than a single childhood febrile seizure
  • History or presence of schizophrenia or other psychotic disorder, bipolar disorder, anorexia, bulimia, alcohol or drug abuse, tardive dyskinesia, or dystonia
  • History or presence of any clinically important medical condition that could be detrimental to the subject or could affect the subject’s ability to complete the study

Based on this information, if you think that you or your child might be a good candidate for this study and would like to be contacted by the study team to find out more, please complete this form.