Safety, Tolerability, Pharmacokinetic, and Efficacy Study... | NCT01904773 | Trialant
NCT01904773
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Sep 23, 2016Estimated
Enrollment
29Actual
Phase
Phase 2
Conditions
Tourette Syndrome
Interventions
AZD5213 and placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01904773
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D3032C00001
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Sep 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2013
Primary Completion Date
Feb 2015Actual
Completion Date
Feb 2015Actual
First Submitted Date
Jul 18, 2013
First Submission Date that Met QC Criteria
Jul 18, 2013
First Posted Date
Jul 22, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 15, 2016
Results First Submitted that Met QC Criteria
Jun 14, 2016
Results First Posted Date
Jul 25, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 22, 2016
Last Update Posted Date
Sep 23, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Tourette Syndrome
Keywords
Combined Multiple Motor and Vocal Tic Disorder; Tourette Disorder; Gilles de la Tourette Syndrome; Tourette Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
29Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Drug: AZD5213 and placebo
low dose AZD5213
Experimental
Drug: AZD5213 and placebo
high dose AZD5213
Experimental
Drug: AZD5213 and placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD5213 and placebo
Drug
low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules
Placebo
high dose AZD5213
low dose AZD5213
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Orange
California
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
There were 29 screening visits for 28 subjects, 1 subject was initially screen failed for exclusion 32 but rescreened and qualified and entered Part 1 of the study(104-4003 rescreened and qualified as 104-4004). Eligible subjects participated in Part 1 and then continued into a randomized 6 period crossover Part 2 of the study
Recruitment Details
Subjects between the ages of 12 and 17 with Tourette's Disorder
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Initial Study
Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
FG001
Part 2 -Sequence BBABBA
B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
Periods
Title
Milestones
Reasons Not Completed
Screen
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
St. Petersburg
Florida
United States
Research Site
Summit
New Jersey
United States
Research Site
New York
New York
United States
Research Site
Cincinnati
Ohio
United States
Research Site
Orem
Utah
United States
Research Site
Salt Lake City
Utah
United States
FG002
Part 2- Sequence BABBAB
B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
FG003
Part 2 - Sequence ABCACB
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
FG004
Part 2- Sequence ACBABC
A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
FG005
Part 2- Sequence BACCAB
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
FG006
Part 2- Sequence BCACBA
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
FG007
Part 2 Sequence CABBAC
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
FG008
Part 2- Seqence CBABCA
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
FG00028 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Screen failure
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1 - Single Dose- AZD5213 0.5 mg
Type
Comment
Milestone Data
STARTED
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1 - Multiple Dose AZD5213 2.0 mg
Type
Comment
Milestone Data
STARTED
FG00024 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Tolerated 2.0 mg in Part 1
FG00020 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Did Not Tolerate 2.0 mg in Part 1
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG00023 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
First Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0064 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Placebo Washout First Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Condition worsened
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Second Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Placebo Washout Second Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Third Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Placebo Washout Third Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Fourth Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Placebo Washout Fourth Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Fifth Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Placebo Washout Fifth Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0072 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Study specific withdrawal criteria
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Sixth Intervention
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0072 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All patients enrolled in Part 1 of the study, 23 of whom continued into Part 2
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Overall Study
Part 1 & Part 2
Denominators
Units
Counts
Participants
BG00024
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Adolescent - age 12 to 17
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00014.6± 1.76
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
Male
BG00020
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
Not Hispanic or Latino
BG00021
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG0001
Nicotine use
Have ever used nicotine, never, past, present response
Number
Participants
Title
Denominators
Categories
Current
Title
Measurements
BG0000
Never
Title
Measurements
BG000
Tourette's Disorder Duration
Tourette's Disorder Duration in months
Median
Full Range
months
Title
Denominators
Categories
Title
Measurements
BG00075(29.8 to 159.4)
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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
All Part 2 participants
Posted
Least Squares Mean
Standard Error
Total Tic Severity Score
3 week period of treatment
ID
Title
Description
OG000
AZD5213 0.5 mg
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
OG001
AZD5213 2.0 mg
Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
OG002
Placebo
Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
Units
Counts
Participants
OG00023
OG00119
OG00221
Title
Denominators
Categories
Title
Measurements
OG00024.32± 2.01
OG00125.41± 2.05
OG00222.99± 2.03
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Comparison with placebo
ANCOVA
Each subject received each treatment multiple times in a crossover design
0.0087
Bonferroni-Holm adjustment, compared with 0.025
Mean Difference (Net)
2.42
Standard Error of the Mean
0.90
No
Superiority or Other
Primary
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
Pharmacokinetic population
Posted
Mean
Standard Deviation
Plasma concentration (ng/ml)
Day 1
ID
Title
Description
OG000
AZD5213 0.5 mg
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
Units
Counts
Participants
OG00023
Primary
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
Pharmacokinetic population
Posted
Mean
Standard Deviation
Time (hr)
Day 1
ID
Title
Description
OG000
AZD5213 0.5 mg
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
Units
Counts
Participants
OG00023
Primary
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)
Pharmacokinetic population
Posted
Mean
Standard Deviation
AUC (h*ng/ml)
Day 1
ID
Title
Description
OG000
AZD5213 0.5 mg
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
Units
Counts
Participants
OG00023
Time Frame
176 days
Description
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Overall Study
Part 1 & Part 2
2
24
22
24
EG001
Part 1 - AZD5213 0.5 mg
Part 1 - Day 1, AZD5213 0.5 mg
0
24
1
24
EG002
Part 1 - AZD5213 2.0 mg
Part 1 - Days 6-8, AZD5213 2.0 mg
1
24
7
24
EG003
Part 2 - AZD5213 0.5 mg
Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
0
23
16
23
EG004
Part 2 - AZD5213 2.0 mg
Part 2 - AZD5213, 2.0 mg periods (2 periods)
0
19
9
19
EG005
Part 2 - Placebo
Part 2 - Placebo periods (2 periods)
1
21
11
21
EG006
Part 1 - Placebo
Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
0
24
5
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Testicular torsion (Part 2)
Reproductive system and breast disorders
MedDRA Version 16.0
Non-systematic Assessment
Surgical orchiectomy required, treatment continued (placebo treatment period)
EG0001 events1 affected23 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected23 at risk
Convulsion
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anxiety
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected23 at risk
EG0041 events1 affected19 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected24 at risk
Confusional State
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0003 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0004 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Tic
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0003 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abnormal behavior
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Agitation
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Impulsive behavior
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Hypervigilance
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sexually inappropriate behavior
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG00017 events9 affected24 at risk
EG0010 events0 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0005 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0006 events6 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Fatigue
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0008 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0023 events2 affected24 at risk
EG003
Feeling abnormal
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Asthenia
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Irritability
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Medical device complication
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pain
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Thirst
General disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0005 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cold Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Orapharangeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Non-systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 16.0
Non-systematic Assessment
EG00010 events6 affected24 at risk
EG0011 events1 affected24 at risk
EG0023 events3 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Joel Posener, MD - Head, Early Clinical Development
AstraZeneca Pharmaceuticals LP, Neuroscience Innovative Medicines Unit
ClinicalTrialTransparency@astrazeneca.net
ID
Term
D005879
Tourette Syndrome
D013981
Tic Disorders
Ancestor Terms
ID
Term
D001480
Basal Ganglia Diseases
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D009069
Movement Disorders
D020271
Heredodegenerative Disorders, Nervous System
D019636
Neurodegenerative Diseases
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D065886
Neurodevelopmental Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
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Unknown or Not Reported
BG0000
Native Hawaiian or Other Pacific Islander
BG0000
Black or African American
BG0002
White
BG00021
More than one race
BG0000
Unknown or Not Reported
BG0000
24
Past
Title
Measurements
BG0000
OG000
OG002
ANCOVA
Each subject received each treatment multiple times in a crossover design