Brief Title
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Official Title
A 6-month, Multicenter, Randomized, Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Brief 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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods
Condition
Tourette Syndrome
Intervention
AZD5213 and placebo
Study Arms / Comparison Groups
Placebo
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
August 2013
Completion Date
February 2015
Primary Completion Date
February 2015
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.
Gender
All
Ages
12 Years - 17 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01904773
Organization ID
D3032C00001
Responsible Party
Sponsor
Study Sponsor
AstraZeneca
Study Sponsor
, ,
Verification Date
September 2016