Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents with Tourette's Disorder

Study identifier:D3032C00001

ClinicalTrials.gov identifier:NCT01904773

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 6-month, Multicenter, Randomized, Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of AZD5213 in Adolescents with Tourette's Disorder

Medical condition

Tourette Syndrome

Phase

Phase 2

Healthy volunteers

Study drug

AZD5213 and placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

12 Years - 17 Years

Date

Study Start Date: 01 Aug 2013

Primary Completion Date: 01 Feb 2015

Study Completion Date: 01 Feb 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Collaborators

Inclusion and exclusion 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.

Location

Research Site

Summit, NJ, United States

Location

Research Site

Cincinnati, OH, United States

Location

Research Site

New York, NY, United States

Location

Research Site

St. Petersburg, FL, United States

Location

Research Site

Orange, CA, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

Orem, UT, United States

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: AZD5213 and placebo low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules
Experimental: low dose AZD5213	Drug: AZD5213 and placebo low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules
Experimental: high dose AZD5213	Drug: AZD5213 and placebo low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules