Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome
Intervention: AZD5213 and placebo
Intervention description: low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Combined Multiple Motor and Vocal Tic Disorder; Tourette Disorder; Gilles de la Tourette Syndrome; Tourette Disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, between the ages of ≥ 12 and < 18 years at baseline (Day 1).

          2. Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision (DSM-IV-TR) criteria for Tourette's Disorder, as assessed by the Kiddie-SADS
             (Schedule for Affective Disorders and Schizophrenia)-Present and Lifetime Version
             (K-SADS-PL) Tic Disorder Supplement and clinical interview.

          3. Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTS) ≥ 20 at Screen
             and baseline (Day 1).

          4. Symptoms of Tourette's Disorder must impair school, occupational, and/or social
             function.

          5. Written informed assent or consent provided by the subject, and written informed
             consent provided by the parent(s)/guardians(s), as appropriate per the Institutional
             Review Board/Ethics Committee. 6. Weight ≥ 40 kg at the screening and baseline (Day 1)
             visits.

        7. In the opinion of the investigator, the subject and designated guardian(s) and/or
        parent(s) must be considered likely to comply with the study protocol and to have a high
        probability of completing the study.

        Exclusion Criteria:

        Subjects should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Prior participation in any AZD5213 study.

          2. Acute suicidality as evidenced by answering "yes" for question #4 or question #5 on
             the Columbia-Suicide Severity Rating Scale (C-SSRS), indicating active suicidal
             ideation with any intent to act, at Screen or baseline (Day 1).

          3. Pregnant or breast-feeding females.

          4. History of seizure disorder other than a single childhood febrile seizure.

          5. Presence of any psychiatric or neurologic disorder or symptom, if, in the judgment of
             the investigator, the psychiatric or neurologic disorder or symptom is likely to
             confound interpretation of drug effect or affect the subject's ability to complete the
             study. 6. Any clinically important abnormality as determined by the investigator at
             Screen or baseline (Day 1) in physical or neurologic examination, vital sign, ECG, or
             clinical laboratory test results that could be detrimental to the subject or could
             affect the subject's ability to complete the study.

        7. History or presence of any clinically important medical condition that, in the judgement
        of the investigator, is likely to deteriorate, could be detrimental to the subject, or
        could affect the subject's ability to complete the study.

        8. History or presence of a clinically important sleep disorder.