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Trial record 16 of 405 for:    ARIPIPRAZOLE

Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

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ClinicalTrials.gov Identifier: NCT01727713
Recruitment Status : Completed
First Posted : November 16, 2012
Results First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tourette's Disorder
Tic Disorder
Intervention Drug: Aripiprazole
Enrollment 110
Recruitment Details The trial was conducted in 110 participants at 37 trials sites in 4 countries. Participants who were aged 7 to 17 years at screening or who turned 18 years during their participation in Trial 31-12-293 (NCT01727700) were enrolled in this extension trial
Pre-assignment Details  
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Period Title: Overall Study
Started 110
Completed 75
Not Completed 35
Reason Not Completed
Lost to Follow-up             5
Adverse Event             10
Participant Met Withdrawal Criteria             5
Withdrawal by Subject             13
Protocol Deviation             2
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
11.7  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
24
  21.8%
Male
86
  78.2%
1.Primary Outcome
Title Percentage of Participants With Adverse Events.
Hide Description An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolonged hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Time Frame Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of participants
Participants with TEAEs 76.4
Participants with severe TEAEs 4.5
Participants with serious TEAEs 3.6
2.Primary Outcome
Title Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.
Hide Description Laboratory tests including hematology, serum chemistry, and urinalysis were performed for all the participants. The central laboratory was used for all laboratory testing whenever possible. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant based on the pre-defined criteria for identifying laboratory values of potential clinical relevance. Percentage of participants noted with abnormal laboratory values are reported below.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline laboratory value were included.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of participants
Eosinophils (high) (N=108) 3.7
Hemoglobin A1C (high) (N=107) 0.9
Absolute neutrophils (low) (N=108) 13.0
White blood count (low) (N=108) 4.6
Total bilirubin (high) (N=108) 1.9
Creatine phosphokinase (high) (N=108) 0.9
Fasting glucose (high) (N=93) 3.2
LDL cholesterol (high) (N=92) 3.3
Triglycerides (high) (N=92) 17.4
Uric acid (high) (N=108) 0.9
Potassium (high) (N=108) 0.9
Urine glucose (high) (N=104) 1.0
Urine protein (high) (N=104) 1.9
Prolactin (high) (N=104) 3.8
3.Primary Outcome
Title Percentage of Participants With Clinically Significant Abnormal Vital Signs.
Hide Description Vital sign measurements included systolic and diastolic blood pressure (BP) and heart rate, which were performed at all clinic visits. Criteria for identifying vital signs of potential clinical relevance included: Heart rate: ≥ 15 beats per minute (bpm) increase/decrease from Baseline (final visit of study 31-12-293); Systolic BP: ≥ 20 mmHg increase/decrease from Baseline; Diastolic BP: ≥ 15mmHg increase/decrease from Baseline; Orthostatic hypotension: ≥ 20 mmHg decrease in systolic BP and a ≥ 25 bpm increase in heart rate from supine to sitting/standing. Percentage of participants noted with abnormal vital sign measurements are reported below.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline vital sign result were included.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of participants
Heart rate-Supine (increase) (N=108) 0.9
Heart rate-Supine (decrease) (N=108) 0.9
Heart rate-Standing (increase) (N=108) 9.3
Systolic Supine BP (decrease) (N=108) 6.5
Systolic Standing BP (decrease) (N=108) 3.7
Diastolic Supine BP (decrease) (N=108) 0.9
Diastolic Standing BP (decrease) (N=108) 5.6
Orthostatic hypotension (N=110) 2.7
4.Primary Outcome
Title Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).
Hide Description Three 12-lead ECGs (scheduled 5 minutes apart) were recorded. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: Tachycardia/sinus tachycardia: increase of ≥15 bpm from Baseline; increase in QTc of ≥10% from Baseline. The other abnormalities not present at Baseline and were present during the time of measurement were recorded. Percentage of participants noted with abnormal ECG findings are reported below.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline ECG result were included.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of participants
Tachycardia (N=106) 0.9
Sinus Tachycardia (N=106) 0.9
Supraventricular premature beat (N=106) 1.9
Ventricular premature beat (N=106) 0.9
Right bundle branch block (N=106) 1.9
QTcB (N=106) 0.9
QTcN (N=106) 0.9
5.Primary Outcome
Title Mean Change From Baseline in Body Weight.
Hide Description Criteria for identifying weight of potential clinical relevance was: ≥ 7% kilogram increase/decrease from Baseline (Final visit of Trial 31-12-293).
Time Frame Baseline to Weeks 12, 28, 36, 44, 52/Last visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline weight measurement.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Kilogram
Week 12 (N=102) 1.8  (2.3)
Week 28 (N=90) 4.8  (3.8)
Week 36 (N=88) 5.8  (4.4)
Week 44 (N=81) 6.8  (5.3)
Week 52 (N=77) 8.0  (5.4)
Last visit (N=106) 7.2  (5.8)
6.Primary Outcome
Title Mean Change From Baseline in Body Mass Index (BMI).
Hide Description BMI was calculated at the Baseline visit (using the Baseline height from study 31-12-293) and at Weeks 28 and 52/ET where height measured at baseline in the current trial was used to calculate BMI.
Time Frame Baseline to Weeks 28, 52 and Last visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline BMI measurement.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Kg/M^2
Week 28 (N=90) 3.3  (16.2)
Week 52 (N=77) 1.9  (2.3)
Last visit (N=106) 1.8  (2.3)
7.Primary Outcome
Title Mean Change From Baseline in Waist Circumference.
Hide Description Waist circumference was measured at Baseline, Weeks 12, 28, 36, 44, and the Week 52/last visit in centimeters.
Time Frame Baseline to Weeks 12, 28, 36, 44, and 52/last visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline waist circumference measurement.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Centimeter
Week 12 (N=102) 2.2  (8.3)
Week 28 (N=90) 3.7  (9.7)
Week 36 (N=87) 3.5  (6.5)
Week 44 (N=80) 4.5  (6.7)
Week 52 (N=75) 5.5  (6.5)
Last visit (N=106) 4.6  (6.4)
8.Primary Outcome
Title Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.
Hide Description The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest, and the investigator also made global judgments on the participant's dyskinesias (items 8 through 10). Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). In addition, the AIMS included 2 yes/no questions that addressed the subject’s dental status (since an edentulous state can cause lingual dyskinesias). The AIMS movement rating score (range 0 to 28) was the sum of the rating scores for facial and oral moments (ie, items 1 to 4), extremity movements (ie, items 5 and 6), and trunk movements (ie, item 7).
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=107) -1.0  (3.0)
Week 8 (N=105) -1.3  (3.4)
Week 12 (N=104) -1.7  (3.7)
Week 20 (N=100) -1.8  (3.9)
Week 28 (N=92) -2.0  (4.3)
Week 36 (N=88) -2.2  (4.5)
Week 44 (N=82) -2.3  (4.6)
Week 52 (N=77) -2.3  (4.7)
Last vist (N=109) -1.8  (4.3)
9.Primary Outcome
Title Change From Baseline in Simpson-Angus Scale (SAS) Total Score.
Hide Description The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS total score (range 10 to 50) was the sum of the rating scores for 10 items from the SAS panel.
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=107) 0.0  (0.9)
Week 8 (N=104) -0.0  (0.9)
Week 12 (N=104) -0.0  (0.9)
Week 20 (N=100) -0.1  (0.7)
Week 28 (N=92) -0.2  (0.8)
Week 36 (N=88) -0.2  (0.8)
Week 44 (N=82) -0.2  (0.8)
Week 52 (N=77) -0.1  (0.8)
Last vist (N=109) -0.1  (0.7)
10.Primary Outcome
Title Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.
Hide Description The BARS Global Score is derived from the global clinical evaluation of akathisia on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=107) 0.0  (0.4)
Week 8 (N=105) 0.0  (0.4)
Week 12 (N=104) -0.0  (0.3)
Week 20 (N=100) -0.1  (0.3)
Week 28 (N=92) -0.1  (0.3)
Week 36 (N=88) -0.1  (0.3)
Week 44 (N=82) -0.1  (0.3)
Week 52 (N=77) -0.1  (0.3)
Last vist (N=109) -0.0  (0.3)
11.Primary Outcome
Title Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).
Hide Description The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline/“since last visit” evaluation that focuses on suicidality since the last trial visit. The C-SSRS data at Baseline and post baseline were summarized for incidence of reporting: Suicidality, Suicidal behavior (and its 4 types), Suicidal ideation (and its 5 types). The intensity score of each item ranges from 1 (least severe) to 5 (most severe), which leads to the range of the total score from 0 to 25.
Time Frame Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N=108) -0.1  (0.7)
Week 2 (N=106) -0.0  (0.5)
Week 4 (N=107) 0.0  (0.8)
Week 8 (N=105) -0.1  (0.8)
Week 12 (N=104) -0.0  (0.5)
Week 20 (N=100) -0.1  (0.5)
Week 28 (N=92) 0.1  (1.0)
Week 36 (N=88) 0.1  (1.3)
Week 44 (N=82) 0.0  (0.0)
Week 52 (N=77) 0.2  (1.3)
Last vist (N=110) 0.0  (1.3)
12.Primary Outcome
Title Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).
Hide Description The SNAP-IV Rating Scale is a revision of the SNAP Questionnaire. The SNAP-IV assesses inattention and hyperactivity/impulsivity, as well as oppositional defiant disorder that are often present in children with ADD/ADHD. The SNAP-IV was administered as a semi-structured interview with the participant and caregiver. The SNAP-IV is based on a 0 to 3 rating scale: not at all = 0, just a little = 1, quite a bit = 2, and very much = 3. The ADD/ADHD subscale includes items 1 through 19 (items 1–9 measure inattention, items 11–19 measure hyperactivity/ impulsivity, and item 10 for inattention domain), items 4, 8, 11, 31, and 32 measure inattention/overactivity, and items 21, 23, 29, 34, and 35 measure aggression/defiance. Items 4, 8, 11, 21, 32, 33, 36, 37, 38, and 39 form the Conners Index. Subscale average scores on the SNAP IV were calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=107) -0.2  (0.4)
Week 8 (N=105) -0.2  (0.4)
Week 12 (N=104) -0.3  (0.4)
Week 20 (N=100) -0.2  (0.4)
Week 28 (N=92) -0.2  (0.4)
Week 36 (N=88) -0.2  (0.4)
Week 44 (N=82) -0.2  (0.4)
Week 52 (N=77) -0.2  (0.4)
Last vist (N=109) -0.2  (0.5)
13.Primary Outcome
Title Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
Hide Description The CY-BOCS is a semi-structured interview used with children and adolescents aged 6 to 17 years to rate the severity and type of symptoms in participants with obsessive compulsive disorder. In general, the items depend on the participant's report; however, the final rating is based on the clinical judgment of the interviewer and should include additional information supplied by others. Nineteen items are rated in the CY-BOCS, but only items 1 through 10 (excluding items lb and 6b) are used to determine the total score. The total CY-BOCS score is the sum of items 1 through 10 (excluding lb and 6b), whereas the obsession and compulsion subtotals are the sums of items 1 through 5 (excluding lb) and 6 through 10 (excluding 6b), respectively. CY-BOCS total score could range from 0 to 40, and the obsession and compulsion subscale total scores could each range from 0 to 20. Higher scores indicate worse outcome.
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=107) -0.2  (2.6)
Week 8 (N=105) -0.1  (3.0)
Week 12 (N=104) -0.5  (2.7)
Week 20 (N=100) -0.6  (3.0)
Week 28 (N=92) -0.5  (3.3)
Week 36 (N=88) -0.7  (3.4)
Week 44 (N=82) -0.8  (3.7)
Week 52 (N=77) -0.9  (3.9)
Last vist (N=109) -0.7  (3.4)
14.Primary Outcome
Title Change From Baseline in Children’s Depression Rating Scale - Revised (CDRS-R).
Hide Description The CDRS-R is a brief rating scale based on a semi-structured interview with the child and an adult informant who knows the child well. Designed for 6- to 12-year-old children, and successfully used with adolescents, it can be administered in 15 to 20 minutes. The interviewer rates 17 symptom areas (including those that serve as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for a diagnosis of depression): impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome.
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=104) -0.4  (4.4)
Week 8 (N=100) -0.4  (3.8)
Week 12 (N=100) -0.3  (3.2)
Week 20 (N=97) -0.1  (4.2)
Week 28 (N=91) 0.2  (5.0)
Week 36 (N=87) 0.4  (4.4)
Week 44 (N=82) -0.3  (3.3)
Week 52 (N=77) 0.6  (3.8)
Last vist (N=107) 0.7  (4.5)
15.Primary Outcome
Title Change From Baseline in Pediatric Anxiety Rating Scale (PARS).
Hide Description The PARS is used to rate the severity of anxiety in children and adolescents, aged 6 to 17 years. The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child’s repertoire of symptoms during the past week. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score was the sum of items 2, 3, 5, 6, and 7. The total severity score ranged from 0 (no anxiety) to 25 (worst anxiety).
Time Frame Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (N=107) -0.3  (3.0)
Week 8 (N=105) -0.3  (3.6)
Week 12 (N=104) -0.5  (2.6)
Week 20 (N=100) -0.4  (2.9)
Week 28 (N=91) -0.2  (3.1)
Week 36 (N=88) -0.7  (3.0)
Week 44 (N=82) -0.5  (2.7)
Week 52 (N=77) -0.4  (3.5)
Last vist (N=109) -0.4  (3.5)
16.Secondary Outcome
Title Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
Hide Description The YGTSS is a semi-structured clinical interview which consists of a tic inventory, with 5 separate ratings to assess the number, intensity, frequency, complexity and interference of tics, plus an overall impairment/disability score. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the secondary outcome measure in this trial. The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. The total severity score ranged from 0 (no impairment) to 50 (worst impairment).
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 52 (N=77) -8.6  (10.2)
Last visit (N=109) -6.6  (10.9)
17.Secondary Outcome
Title Mean Clinical Global Impressions for Tourette’s Syndrome (CGI-TS) Change Score at Endpoint.
Hide Description The CGI is a 7-point Likert scale used in a multitude of clinical trials as a clinical global measure to assess the severity and change in disease symptomatology (ie, tics). The CGI was included as a secondary scale to provide a more complete assessment of clinical efficacy. To assess CGI-TS severity, the rater or investigator will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness will be limited to manifestations of Tourette’s Disorder only. Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 52 (N=77) 2.5  (1.6)
Last visit (N=109) 2.5  (1.6)
18.Secondary Outcome
Title Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.
Hide Description The final CGI-TS score was compared to the participant’s baseline condition at the time of entry into the open-label study, rather than the CGI-TS baseline condition at the time participants enrolled into the preceding study. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 52 (N=77) -0.9  (1.2)
Last visit (N=109) -0.7  (1.3)
19.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Total YGTSS Score.
Hide Description The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) for motor and vocal tics, and an impairment ranking. The YGTSS TTS is the summation of the severity scores of motor and vocal tics (range of 0 [no impairment] to 50 [maximum impairment]). The total YGTSS score is the summation of the severity scores of motor and vocal tics and the ranking of impairment (total range of 0 [no impairment] to 100 [maximum impairment]).
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 52 (N=77) -18.0  (23.7)
Last visit (N=109) -14.0  (24.3)
20.Secondary Outcome
Title Percentage of Participants With Response (Response Rate).
Hide Description Clinical response was defined as > 25% improvement from Baseline to endpoint in YGTSS TTS or a CGI-TS change score of 1 (very much improved) or 2 (much improved) at endpoint.
Time Frame Weeks 4, 8, 12, 20, 28, 36, 44 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of participants with response
Week 4 (N=107) 80.4
Week 8 (N=105) 81.9
Week 12 (N=104) 82.7
Week 20 (N=100) 75.0
Week 28 (N=92) 77.2
Week 36 (N=88) 75.0
Week 44 (N=81) 75.3
Week 52 (N=77) 67.5
21.Secondary Outcome
Title Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).
Hide Description The treatment discontinuation rate was calculated as the number of discontinued participants (ie, those withdrawn from the study without completing the Week 52 visit) divided by the number of all enrolled participants.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description:
All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of discontinued participants
31.8
Time Frame Day 0 (Baseline) until Follow-up 30 Days (±3 days) after the last trial visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label Aripiprazole
Hide Arm/Group Description All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
All-Cause Mortality
Open-label Aripiprazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-label Aripiprazole
Affected / at Risk (%) # Events
Total   4/110 (3.64%)    
Congenital, familial and genetic disorders   
Tourette's disorder * 1  1/110 (0.91%)  1
Infections and infestations   
Appendicitis * 1  1/110 (0.91%)  1
Infectious mononucleosis * 1  1/110 (0.91%)  1
Injury, poisoning and procedural complications   
Concussion * 1  1/110 (0.91%)  1
Intentional overdose * 1  1/110 (0.91%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-label Aripiprazole
Affected / at Risk (%) # Events
Total   84/110 (76.36%)    
Blood and lymphatic system disorders   
Leukopenia * 1  1/110 (0.91%)  1
Neutropenia * 1  2/110 (1.82%)  2
Cardiac disorders   
Tachycardia * 1  1/110 (0.91%)  1
Ear and labyrinth disorders   
Ear pain * 1  1/110 (0.91%)  1
Middle ear effusion * 1  1/110 (0.91%)  1
Tympanic membrane perforation * 1  1/110 (0.91%)  1
Eye disorders   
Excessive eye blinking * 1  1/110 (0.91%)  1
Eye inflammation * 1  1/110 (0.91%)  1
Strabismus * 1  1/110 (0.91%)  1
Vision blurred * 1  2/110 (1.82%)  2
Gastrointestinal disorders   
Abdominal discomfort * 1  1/110 (0.91%)  1
Abdominal pain * 1  1/110 (0.91%)  2
Abdominal pain upper * 1  2/110 (1.82%)  2
Aphthous stomatitis * 1  1/110 (0.91%)  2
Constipation * 1  3/110 (2.73%)  4
Diarrhoea * 1  3/110 (2.73%)  3
Dry mouth * 1  1/110 (0.91%)  1
Eructation * 1  1/110 (0.91%)  2
Flatulence * 1  1/110 (0.91%)  1
Nausea * 1  8/110 (7.27%)  9
Retching * 1  1/110 (0.91%)  1
Salivary hypersecretion * 1  2/110 (1.82%)  3
Vomiting * 1  10/110 (9.09%)  12
General disorders   
Fatigue * 1  11/110 (10.00%)  12
Influenza like illness * 1  1/110 (0.91%)  1
Irritability * 1  2/110 (1.82%)  3
Malaise * 1  1/110 (0.91%)  1
Pyrexia * 1  7/110 (6.36%)  8
Hepatobiliary disorders   
Hepatitis acute * 1  1/110 (0.91%)  1
Immune system disorders   
House dust allergy * 1  1/110 (0.91%)  1
Multiple allergies * 1  1/110 (0.91%)  1
Seasonal allergy * 1  3/110 (2.73%)  3
Infections and infestations   
Ear infection * 1  2/110 (1.82%)  2
Gastroenteritis * 1  5/110 (4.55%)  5
Gastroenteritis viral * 1  4/110 (3.64%)  5
Gastrointestinal viral infection * 1  1/110 (0.91%)  1
Influenza * 1  4/110 (3.64%)  4
Localised infection * 1  1/110 (0.91%)  1
Nasopharyngitis * 1  11/110 (10.00%)  12
Otitis media * 1  1/110 (0.91%)  1
Pharyngitis * 1  1/110 (0.91%)  1
Pharyngitis streptococcal * 1  2/110 (1.82%)  2
Pneumonia * 1  1/110 (0.91%)  2
Sinusitis * 1  5/110 (4.55%)  5
Tonsillitis * 1  1/110 (0.91%)  1
Upper respiratory tract infection * 1  4/110 (3.64%)  4
Viral infection * 1  2/110 (1.82%)  2
Viral rash * 1  1/110 (0.91%)  1
Injury, poisoning and procedural complications   
Animal bite * 1  1/110 (0.91%)  1
Contusion * 1  1/110 (0.91%)  1
Excoriation * 1  1/110 (0.91%)  1
Hand fracture * 1  1/110 (0.91%)  1
Ligament sprain * 1  2/110 (1.82%)  2
Patella fracture * 1  1/110 (0.91%)  1
Investigations   
Bilirubin conjugated increased * 1  1/110 (0.91%)  1
Blood creatine phosphokinase increased * 1  1/110 (0.91%)  1
Blood pressure increased * 1  1/110 (0.91%)  1
Blood thyroid stimulating hormone increased * 1  1/110 (0.91%)  1
Protein urine present * 1  1/110 (0.91%)  1
Weight increased * 1  26/110 (23.64%)  27
White blood cell count decreased * 1  1/110 (0.91%)  1
Metabolism and nutrition disorders   
Hyperinsulinaemia * 1  2/110 (1.82%)  2
Increased appetite * 1  6/110 (5.45%)  6
Insulin resistance * 1  1/110 (0.91%)  1
Iron deficiency * 1  1/110 (0.91%)  1
Vitamin D deficiency * 1  1/110 (0.91%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/110 (0.91%)  1
Muscle spasms * 1  1/110 (0.91%)  1
Pain in extremity * 1  3/110 (2.73%)  3
Nervous system disorders   
Akathisia * 1  3/110 (2.73%)  3
Cognitive disorder * 1  1/110 (0.91%)  1
Dizziness * 1  5/110 (4.55%)  6
Dyskinesia * 1  1/110 (0.91%)  1
Dystonia * 1  2/110 (1.82%)  2
Headache * 1  11/110 (10.00%)  12
Migraine * 1  1/110 (0.91%)  1
Migraine with aura * 1  1/110 (0.91%)  1
Paresthesia * 1  1/110 (0.91%)  1
Psychomotor hyperactivity * 1  1/110 (0.91%)  1
Sedation * 1  6/110 (5.45%)  6
Somnolence * 1  13/110 (11.82%)  14
Syncope * 1  1/110 (0.91%)  1
Tremor * 1  2/110 (1.82%)  2
Psychiatric disorders   
Aggression * 1  3/110 (2.73%)  4
Agitation * 1  4/110 (3.64%)  6
Anger * 1  2/110 (1.82%)  2
Anxiety * 1  6/110 (5.45%)  6
Attention deficit/hyperactivity disorder * 1  5/110 (4.55%)  6
Blunted affect * 1  1/110 (0.91%)  1
Bruxism * 1  1/110 (0.91%)  1
Depression * 1  2/110 (1.82%)  3
Depressed mood * 1  2/110 (1.82%)  2
Emotional disorder * 1  1/110 (0.91%)  1
Emotional poverty * 1  1/110 (0.91%)  1
Flat affect * 1  1/110 (0.91%)  1
Head banging * 1  1/110 (0.91%)  1
Initial insomnia * 1  1/110 (0.91%)  1
Insomnia * 1  3/110 (2.73%)  3
Mood altered * 1  1/110 (0.91%)  1
Obsessive-compulsive disorder * 1  1/110 (0.91%)  1
Restlessness * 1  1/110 (0.91%)  1
Sleep disorder * 1  1/110 (0.91%)  1
Somnambulism * 1  1/110 (0.91%)  1
Suicidal ideation * 1  3/110 (2.73%)  3
TIC * 1  6/110 (5.45%)  9
Renal and urinary disorders   
Pollakiuria * 1  1/110 (0.91%)  1
Urinary hesitation * 1  1/110 (0.91%)  1
Urinary incontinence * 1  1/110 (0.91%)  1
Urinary retention * 1  1/110 (0.91%)  1
Reproductive system and breast disorders   
Dysmenorrhoea * 1  2/110 (1.82%)  2
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/110 (1.82%)  3
Epistaxis * 1  2/110 (1.82%)  4
Hiccups * 1  1/110 (0.91%)  1
Nasal congestion * 1  1/110 (0.91%)  2
Oropharyngeal pain * 1  3/110 (2.73%)  3
Rhinitis allergic * 1  1/110 (0.91%)  1
Rhinorrhoea * 1  3/110 (2.73%)  4
Sleep apnoea syndrome * 1  1/110 (0.91%)  1
Vocal cord disorder * 1  1/110 (0.91%)  1
Skin and subcutaneous tissue disorders   
Acne * 1  1/110 (0.91%)  1
Rash * 1  1/110 (0.91%)  1
Vascular disorders   
Hot flush * 1  1/110 (0.91%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01727713     History of Changes
Other Study ID Numbers: 31-12-294
First Submitted: November 12, 2012
First Posted: November 16, 2012
Results First Submitted: August 4, 2015
Results First Posted: October 16, 2015
Last Update Posted: October 16, 2015