Status:
COMPLETED
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Lead Sponsor:
AstraZeneca
Conditions:
Tourette Syndrome
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
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 ...
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, ...
Eligibility Criteria
Inclusion
- Male or female, between the ages of ≥ 12 and \< 18 years at baseline (Day 1).
- 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.
- Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTS) ≥ 20 at Screen and baseline (Day 1).
- Symptoms of Tourette's Disorder must impair school, occupational, and/or social function.
- 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
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Prior participation in any AZD5213 study.
- 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).
- Pregnant or breast-feeding females.
- History of seizure disorder other than a single childhood febrile seizure.
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01904773
Start Date
August 1 2013
End Date
February 1 2015
Last Update
September 23 2016
Active Locations (7)
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1
Research Site
Orange, California, United States
2
Research Site
St. Petersburg, Florida, United States
3
Research Site
Summit, New Jersey, United States
4
Research Site
New York, New York, United States