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

NCT01904773 | Completed Phase 2 Results

• 1 other identifier: D3032C00001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 7

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.

Conditions

Tourette Syndrome

Keywords

Combined Multiple Motor and Vocal Tic Disorder; Tourette Disorder; Gilles de la Tourette Syndrome; Tourette Disease

Outcome Measures

Primary Outcomes (4)

• Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods

  Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50

  3 week period of treatment

• Pharmacokinetics : Maximum Plasma Concentration (ng/ml) - Part 1 Only

  Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg

  Day 1

• Pharmacokinetics : Time to Maximum Concentration (hr) - Part 1 Only

  Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg

  Day 1

• Pharmacokinetics : AUC (h*ng/ ml) - Part 1 Only

  Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h\*ng/ml)

  Day 1

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: AZD5213 and placebo

low dose AZD5213

EXPERIMENTAL

Drug: AZD5213 and placebo

high dose AZD5213

EXPERIMENTAL

Drug: AZD5213 and placebo

Interventions

AZD5213 and placebo DRUG

low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules

Placebo; high dose AZD5213; low dose AZD5213

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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.
• \. 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.
• \. History or presence of a clinically important sleep disorder.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Orange, California, United States

Location

Research Site

St. Petersburg, Florida, United States

Location

Research Site

Summit, New Jersey, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Orem, Utah, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Joel Posener, MD - Head, Early Clinical Development
• Organization: AstraZeneca Pharmaceuticals LP, Neuroscience Innovative Medicines Unit

ClinicalTrialTransparency@astrazeneca.net

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 22, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 23, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-09

Locations

US (7)