Tourette's Disorder
Conditions
Keywords
Tourette's Disorder, Tic Disorders
Brief summary
The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
Interventions
DRUGAripiprazole
Aripiprazole tablets orally once daily.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* The participants successfully completed the final assessment visit in either Study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial. * Written informed consent form (ICF) obtained from a legally acceptable representative & informed assent at Baseline as applicable by trial center's Institutional review board/independent ethics committee (IRB/IEC). * The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
Exclusion criteria
* The participants experienced adverse events (AEs) during the double-blind study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's judgment, preclude further exposure to aripiprazole. * The participants had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the participant a poor candidate for the trial. * A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1. * Sexually active patients who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 and 30 days following the last dose of study drug for male and female respectively. * Participants representing Risk of committing suicide. * Body weight lower than 16 kg. * Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate aminotransferase, Alanine aminotransferase, Creatinine) vital signs and Electrocardiogram (ECG) results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Waist Circumference | Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) | Waist circumference was recorded before a participant's meal and at approximately the same time at each visit. Measurement was accomplished by locating the upper hip bone and the top of the right iliac crest and placing the measuring tape in a horizontal plane around the abdomen at the level of the crest. Before reading the tape measure, the assessor assured that the tape was snug, but did not compress the skin, and is parallel to the floor. The measurement was made at the end of a normal exhalation. |
| Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The SNAP-IV, ADHD Inattention subscale contains 19 items, items 1 to 9 measure inattention, items 11 to 19 measure hyperactivity/impulsivity, and item 10 for inattention domain that scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 57. The negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The CY-BOCS is used to assess characteristics of obsession and compulsion for the week prior to the interview. Nineteen items are rated in the CY-BOCS, but the total score is the sum of only items 1 to 10 (excluding items 1b and 6b). The obsession and compulsion subtotals are the sums of items 1 to 5 (excluding 1b) and 6 to 10 (excluding 6b), respectively. A missing value for any CY-BOCS item scale could result in a missing total score or obsession and compulsion subtotals of which the item scale is a component. At baseline, the full CY-BOCS interview is conducted. At all post-baseline time points, the Questions on Obsessions (items 1 to 5) and Questions on Compulsions (items 6 to 10) are reviewed and the target symptoms identified at baseline are the primary focus for rating severity. CY-BOCS total score could range from 0 to 40. Higher scores indicate worse outcome. A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The CDRS-R is composed of 17 interviewer-rated symptom areas: 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. A missing value for any CDRS-R item scale or a not rated item scale (indicated by the value of 0) could result in a missing total score. 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. A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | 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. Information is elicited from the child and parent(s) and the rater then combines information from all informants using his/her best judgment. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS rating 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 is the sum of items 2, 3, 5, 6, and 7. The total severity score ranges from 0 to 25, with 25 being the worst. Codes 8 (Not applicable) and 9 (Does not know) are not included in the summation (ie, equivalent to a score of 0 in the summation). A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Body Weight | Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | From signing of the informed consent up to 30 days after the last dose (Up to Week 52) | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration. |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Baseline to Week 52 | The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Baseline to Week 52 | Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported. |
| Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline to Week 52 | Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The AIMS Scale is an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10) are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Body Mass Index (BMI) | Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) | The BMI kilogram/meter square (i.e. kg/m\^2) was calculated from the Baseline height and the weight at the current visit using one of the following formulae, as appropriate: Weight (kg) divided by \[Height (meters)\]\^2. |
| Number of Participants With Clinically Significant Changes in Vital Signs | Baseline to Week 52 | Vital signs assessments included orthostatic (supine and standing) blood pressure (BP) measured as millimeter of mercury \[mmHg\]), heart rate, (measured in beats per minute \[bpm\]), body weight (measured in kilograms \[kg\]) and body temperature. Incidence of clinically relevant abnormal values in heart rate, systolic and diastolic blood pressure and weight were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant has been supine for at least 5 minutes and again after the participant has been standing for approximately 2 minutes, but not more than 3 minutes. |
| Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The SAS is a rating scale used to measure Extrapyramidal symptoms (EPS). The SAS scale 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), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician rated the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). 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. A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in Total YGTSS Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | 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) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A negative change in Total YGTSS score from baseline represents an improvement in symptoms. |
| Response Rates | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Response rates - clinical response was defined as percentage of participants \>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. 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) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100) with higher score representing severe symptoms. |
| Treatment Discontinuation Rates | Up to Week 53 | Treatment discontinuation rate was calculated as the percentage of participants who discontinued treatment. |
| Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score | Baseline and Weeks 4, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) | The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette's Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette's Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life). A positive change from Baseline indicates improvement. |
| Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were 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. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms (A negative change from Baseline indicates improvement). |
Countries
Bulgaria, Canada, Germany, Hungary, Mexico, Romania, South Korea, Taiwan, Ukraine, United States
Participant flow
Recruitment details
A total of 170 participants were screened and enrolled. 114 participants were enrolled from study 31-10-272 (NCT01418339) and 56 participants were enrolled from study 31-10-273 (NCT01418352). The participants were recruited at 79 sites in following 10 countries: Bulgaria, Canada, Germany, Hungary, Mexico, Romania, South Korea, Taiwan, Ukraine and the US from 19 October 2011 to 13 March 2014.
Pre-assignment details
Children and adolescents with Tourette's disorder who had successfully completed the previous studies, entered this 52-week open-label extension study to receive once-weekly aripiprazole tablet.
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole (Once Weekly) Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability. | 170 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Investigator Withdrew Subject | 2 |
| Overall Study | Lack of Efficacy as Determined by the Investigator | 3 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Sponsor Discontinued Trial Site | 43 |
| Overall Study | Subject Met Withdrawal Criteria | 10 |
| Overall Study | Subject Withdrew Consent | 12 |
Baseline characteristics
| Characteristic | Aripiprazole (Once Weekly) |
|---|---|
| Age, Continuous | 12.2 years STANDARD_DEVIATION 2.9 |
| Body Mass Index (BMI) | 21.0 Kilogram per meter square STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Height | 154.2 centimeter STANDARD_DEVIATION 16.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 36 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 117 Participants |
| Region of Enrollment Bulgaria | 5 participants |
| Region of Enrollment Canada | 19 participants |
| Region of Enrollment Germany | 3 participants |
| Region of Enrollment Hungary | 14 participants |
| Region of Enrollment Mexico | 14 participants |
| Region of Enrollment Romania | 8 participants |
| Region of Enrollment South Korea | 15 participants |
| Region of Enrollment Taiwan | 21 participants |
| Region of Enrollment Ukraine | 21 participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 125 Participants |
| Time since first diagnosis for Tourette's Disorder | 2.3 Years STANDARD_DEVIATION 2.5 |
| Weight | 51.5 Kilogram STANDARD_DEVIATION 19 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 170 |
| other Total, other adverse events | 57 / 170 |
| serious Total, serious adverse events | 5 / 170 |
Outcome results
Primary
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score
The AIMS Scale is an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10) are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 4 | -0.1 score on a scale | Standard Deviation 1.3 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 8 | -0.1 score on a scale | Standard Deviation 1.6 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 12 | -0.4 score on a scale | Standard Deviation 1.7 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 16 | -0.5 score on a scale | Standard Deviation 2 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 20 | -0.5 score on a scale | Standard Deviation 2 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 24 | -0.6 score on a scale | Standard Deviation 2.5 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 32 | -0.8 score on a scale | Standard Deviation 2.3 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 40 | -0.8 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Week 52 | -0.9 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Change at Last Visit (Early Termination Visit Prior to or at Week 52 | -0.8 score on a scale | Standard Deviation 2.3 |
Primary
Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV)
The SNAP-IV, ADHD Inattention subscale contains 19 items, items 1 to 9 measure inattention, items 11 to 19 measure hyperactivity/impulsivity, and item 10 for inattention domain that scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 57. The negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 4 | -0.1 score on a scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 8 | 0 score on a scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 12 | -0.1 score on a scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 16 | -0.1 score on a scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 20 | -0.1 score on a scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 24 | -0.2 score on a scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 32 | -0.2 score on a scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 40 | -0.2 score on a scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Week 52 | -0.1 score on a scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -0.1 score on a scale | Standard Deviation 0.4 |
Primary
Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score
The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 4 | 0 score on a scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 8 | 0 score on a scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 12 | 0 score on a scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 16 | 0 score on a scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 20 | 0 score on a scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 24 | 0 score on a scale | Standard Deviation 0.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 32 | 0 score on a scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 40 | 0 score on a scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Week 52 | 0 score on a scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | 0 score on a scale | Standard Deviation 0.3 |
Primary
Mean Change From Baseline in Body Mass Index (BMI)
The BMI kilogram/meter square (i.e. kg/m\^2) was calculated from the Baseline height and the weight at the current visit using one of the following formulae, as appropriate: Weight (kg) divided by \[Height (meters)\]\^2.
Time frame: Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Mass Index (BMI) | Change at Week 12 | 0.6 kg/m^2 | Standard Deviation 0.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Mass Index (BMI) | Change at Week 24 | 0.4 kg/m^2 | Standard Deviation 1.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Mass Index (BMI) | Change at Week 52 | 0.7 kg/m^2 | Standard Deviation 2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Mass Index (BMI) | Change at Last Visit (Early Termination Visit Prior to or at Week 52 | 0.6 kg/m^2 | Standard Deviation 1.8 |
Primary
Mean Change From Baseline in Body Weight
Time frame: Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Weight | Change at Week 12 | 1.4 kilogram | Standard Deviation 2.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Weight | Change at Week 24 | 2.5 kilogram | Standard Deviation 3.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Weight | Change at Week 52 | 4.7 kilogram | Standard Deviation 6 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Body Weight | Change at Last Visit (Week 52 or early termination Visit before Week 52) | 3.8 kilogram | Standard Deviation 5.1 |
Primary
Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score
The CDRS-R is composed of 17 interviewer-rated symptom areas: 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. A missing value for any CDRS-R item scale or a not rated item scale (indicated by the value of 0) could result in a missing total score. 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. A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 4 | 0 score on a scale | Standard Deviation 2.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 8 | 0 score on a scale | Standard Deviation 2.6 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 12 | -0.2 score on a scale | Standard Deviation 3.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 16 | -0.4 score on a scale | Standard Deviation 2.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 20 | -0.3 score on a scale | Standard Deviation 3.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 24 | -0.2 score on a scale | Standard Deviation 2.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 32 | -0.1 score on a scale | Standard Deviation 2.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 40 | -0.4 score on a scale | Standard Deviation 2.7 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Week 52 | -0.2 score on a scale | Standard Deviation 3.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | 0.3 score on a scale | Standard Deviation 4.1 |
Primary
Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score
The CY-BOCS is used to assess characteristics of obsession and compulsion for the week prior to the interview. Nineteen items are rated in the CY-BOCS, but the total score is the sum of only items 1 to 10 (excluding items 1b and 6b). The obsession and compulsion subtotals are the sums of items 1 to 5 (excluding 1b) and 6 to 10 (excluding 6b), respectively. A missing value for any CY-BOCS item scale could result in a missing total score or obsession and compulsion subtotals of which the item scale is a component. At baseline, the full CY-BOCS interview is conducted. At all post-baseline time points, the Questions on Obsessions (items 1 to 5) and Questions on Compulsions (items 6 to 10) are reviewed and the target symptoms identified at baseline are the primary focus for rating severity. CY-BOCS total score could range from 0 to 40. Higher scores indicate worse outcome. A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 4 | -0.2 score on a scale | Standard Deviation 1.6 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 8 | -0.2 score on a scale | Standard Deviation 1.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 12 | -0.3 score on a scale | Standard Deviation 1.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 16 | -0.4 score on a scale | Standard Deviation 1.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 20 | -0.4 score on a scale | Standard Deviation 2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 24 | -0.5 score on a scale | Standard Deviation 2.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 32 | -0.6 score on a scale | Standard Deviation 2.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 40 | -0.6 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Week 52 | -0.3 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -0.3 score on a scale | Standard Deviation 2.4 |
Primary
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score
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. Information is elicited from the child and parent(s) and the rater then combines information from all informants using his/her best judgment. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS rating 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 is the sum of items 2, 3, 5, 6, and 7. The total severity score ranges from 0 to 25, with 25 being the worst. Codes 8 (Not applicable) and 9 (Does not know) are not included in the summation (ie, equivalent to a score of 0 in the summation). A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 4 | -0.1 score on a scale | Standard Deviation 2.6 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 8 | -0.2 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 12 | -0.3 score on a scale | Standard Deviation 1.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 16 | -0.3 score on a scale | Standard Deviation 2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 20 | -0.3 score on a scale | Standard Deviation 2.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 24 | -0.3 score on a scale | Standard Deviation 2.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 32 | -0.3 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 40 | -0.6 score on a scale | Standard Deviation 2.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Week 52 | -0.7 score on a scale | Standard Deviation 2.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -0.3 score on a scale | Standard Deviation 2.6 |
Primary
Mean Change From Baseline in Simpson Angus Scale (SAS) Score
The SAS is a rating scale used to measure Extrapyramidal symptoms (EPS). The SAS scale 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), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 4 | 0 score on scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 8 | 0 score on scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 12 | 0 score on scale | Standard Deviation 0.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 16 | 0 score on scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 20 | 0 score on scale | Standard Deviation 0.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 24 | 0 score on scale | Standard Deviation 0.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 32 | 0 score on scale | Standard Deviation 0.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 40 | 0 score on scale | Standard Deviation 0.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Week 52 | 0 score on scale | Standard Deviation 0.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | 0 score on scale | Standard Deviation 0.4 |
Primary
Mean Change From Baseline in Waist Circumference
Waist circumference was recorded before a participant's meal and at approximately the same time at each visit. Measurement was accomplished by locating the upper hip bone and the top of the right iliac crest and placing the measuring tape in a horizontal plane around the abdomen at the level of the crest. Before reading the tape measure, the assessor assured that the tape was snug, but did not compress the skin, and is parallel to the floor. The measurement was made at the end of a normal exhalation.
Time frame: Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Waist Circumference | Change at Week 12 | 0.4 centimeter | Standard Deviation 3.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Waist Circumference | Change at Week 24 | 1 centimeter | Standard Deviation 5.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Waist Circumference | Change at Week 52 | 2.3 centimeter | Standard Deviation 6.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Waist Circumference | Change at Last Visit (Week 52 or early termination Visit before Week 52) | 1.9 centimeter | Standard Deviation 5.8 |
Primary
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported.
Time frame: Baseline to Week 52
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study, with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Tachycardia | 1 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Bradycardia | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Sinus Tachycardia | 1 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Sinus Bradycardia | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Supraventricular Premature Beat | 4 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Ventricular Premature Beat | 3 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Supraventricular Tachycardia | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Ventricular Tachycardia | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Atrial Fibrillation | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Atrial Flutter | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Primary Atrioventricular Block | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Secondary Atrioventricular Block | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Tertiary Atrioventricular Block | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Left Bundle Branch Block | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Right Bundle Branch Block | 2 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Pre-excitation Syndrome | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Other intraventricular conduction block | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Acute or Sub-acute Infarction | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Old Infarction | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Myocardial Ischemia | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Symmetrical T-Wave Inversion | 1 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | QT Interval cCorrected for Heart Rate by Bazett's Formula (QTB) | 3 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | QT Interval Corrected for Heart Rate by Fredericia's Formula (QTcF) | 0 participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | QT Interval Corrected for Heart Rate by the US Food and Drug (QTcN) | 1 participants |
Primary
Number of Participants With Clinically Significant Changes in Laboratory Parameter Values
The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance.
Time frame: Baseline to Week 52
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses of the specific category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Alkaline Phosphatase | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Alanine Aminotransferase | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Aspartate Aminotransferase | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Bilirubin, Total | 4 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Calcium | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Chloride | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Creatine Phosphokinase | 4 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Creatinine | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Glucose | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Glucose, Fasting | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-HDL Cholesterol, Fasting | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Lactic Dehydrogenase | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-LDL-Cholesterol, Fasting | 2 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Potassium | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Sodium | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry- Triglycerides, Fasting | 19 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry- Urea Nitrogen | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Chemistry-Uric Acid | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Urinalysis-Glucose, Urine | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Urinalysis-Protein, Urine | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Other-Prolactin | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Haematology-Eosinophils | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Haematology-Hematocrit | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Haematology-Hemoglobin | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Haematology-Neutrophils | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Haematology-Platelet Count | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Haematology-White Blood Count | 4 Participants |
Primary
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs assessments included orthostatic (supine and standing) blood pressure (BP) measured as millimeter of mercury \[mmHg\]), heart rate, (measured in beats per minute \[bpm\]), body weight (measured in kilograms \[kg\]) and body temperature. Incidence of clinically relevant abnormal values in heart rate, systolic and diastolic blood pressure and weight were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant has been supine for at least 5 minutes and again after the participant has been standing for approximately 2 minutes, but not more than 3 minutes.
Time frame: Baseline to Week 52
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses of the specific category at given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Heart Rate Supine- Increase ≥15 bpm | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Heart Rate Supine- Decrease ≥15 bpm | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Heart Rate Standing-increase ≥15 bpm | 4 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Heart Rate Standing- Decrease ≥15 bpm | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Systolic Supine BP- Increase ≥20 mmHg | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Systolic Supine BP- Decrease ≥20 mmHg | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Systolic Standing BP- Increase ≥20 mmHg | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Systolic Standing BP- Decrease ≥20 mmHg | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Diastolic Supine BP- Increase ≥15 mmHg | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Diastolic Supine BP- Decrease ≥15 mmHg | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Diastolic Standing BP- Increase ≥15 mmHg | 1 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Diastolic Standing BP- Decrease ≥15 mmHg | 0 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Orthostatic Hypotension | 2 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Weight-Gain ≥ 7% | 82 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Clinically Significant Changes in Vital Signs | Weight-Loss ≥ 7% | 6 Participants |
Primary
Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.
Time frame: Baseline to Week 52
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses of the specific category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Emergence of Suicidal Ideation | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) | TEAEs related to Suicide | 3 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidality and Suicidal Ideation | 4 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration.
Time frame: From signing of the informed consent up to 30 days after the last dose (Up to Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Participants with Serious TEAEs | 5 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Participants with Severe TEAEs | 8 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Participants Discontinued Medication due to TEAE's | 6 Participants |
| Aripiprazole (Once Weekly) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Participants with TEAEs | 104 Participants |
Secondary
Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score
The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician rated the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). 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. A negative change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Efficacy Sample included all participants who received at least one dose of open-label study medication in this study and had a baseline and at least one post baseline efficacy evaluation. Number analyzed is the number of participants with data available for the analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 4 | -0.2 score on a scale | Standard Deviation 0.7 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 8 | -0.4 score on a scale | Standard Deviation 0.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 12 | -0.4 score on a scale | Standard Deviation 0.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 16 | -0.5 score on a scale | Standard Deviation 0.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 20 | -0.6 score on a scale | Standard Deviation 0.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 24 | -0.5 score on a scale | Standard Deviation 0.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 32 | -0.6 score on a scale | Standard Deviation 1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 40 | -0.7 score on a scale | Standard Deviation 1.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Week 52 | -0.7 score on a scale | Standard Deviation 1.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -0.6 score on a scale | Standard Deviation 1.1 |
Secondary
Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score
The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette's Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette's Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life). A positive change from Baseline indicates improvement.
Time frame: Baseline and Weeks 4, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
Population: Efficacy Sample included all participants who received at least one dose of open-label study medication in this study and had a baseline and at least one post baseline efficacy evaluation. Number analyzed is the number of participants with data available for the analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score | Change at Week 4 | -2.9 score on a scale | Standard Deviation 8.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score | Change at Week 24 | -3.6 score on a scale | Standard Deviation 11.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score | Change at Week 52 | -4.3 score on a scale | Standard Deviation 10.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -3.8 score on a scale | Standard Deviation 10.9 |
Secondary
Mean Change From Baseline in Total YGTSS Score
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) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A negative change in Total YGTSS score from baseline represents an improvement in symptoms.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for the analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 4 | -5.6 score on a scale | Standard Deviation 10.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 8 | -7.4 score on a scale | Standard Deviation 11.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 12 | -8.6 score on a scale | Standard Deviation 12.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 16 | -9.4 score on a scale | Standard Deviation 13.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 20 | -10.7 score on a scale | Standard Deviation 14.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 24 | -10.4 score on a scale | Standard Deviation 16 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 32 | -11.6 score on a scale | Standard Deviation 17.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 40 | -12.6 score on a scale | Standard Deviation 17.5 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Week 52 | -10.8 score on a scale | Standard Deviation 17.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Total YGTSS Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -11.4 score on a scale | Standard Deviation 16.7 |
Secondary
Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were 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. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms (A negative change from Baseline indicates improvement).
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 4 | -2.6 score on scale | Standard Deviation 5.4 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 8 | -3.8 score on scale | Standard Deviation 5.6 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 12 | -4.5 score on scale | Standard Deviation 6.7 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 16 | -4.6 score on scale | Standard Deviation 6.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 20 | -5.5 score on scale | Standard Deviation 7.2 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 24 | -5.8 score on scale | Standard Deviation 7.9 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 32 | -6 score on scale | Standard Deviation 9.1 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 40 | -6.4 score on scale | Standard Deviation 9.3 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Week 52 | -5.8 score on scale | Standard Deviation 8.8 |
| Aripiprazole (Once Weekly) | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score | Change at Last Visit (Week 52 or early termination Visit before Week 52) | -5.9 score on scale | Standard Deviation 8.4 |
Secondary
Response Rates
Response rates - clinical response was defined as percentage of participants \>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. 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) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100) with higher score representing severe symptoms.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
Population: Efficacy Sample included all participants who received at least one dose of open-label study medication in this study and had a baseline and at least one post baseline efficacy evaluation. Number analyzed is the number of participants with data available for the analyses at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Response Rates | Week 40 | 80.8 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 52 | 76.5 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 4 | 66.2 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 8 | 69.7 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 12 | 72.6 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 16 | 72.3 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 20 | 74.2 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 24 | 71.8 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Week 32 | 77.8 percentage of participants |
| Aripiprazole (Once Weekly) | Response Rates | Last Visit (Week 52 or early termination Visit before Week 52) | 71.3 percentage of participants |
Secondary
Treatment Discontinuation Rates
Treatment discontinuation rate was calculated as the percentage of participants who discontinued treatment.
Time frame: Up to Week 53
Population: Enrolled Sample include all participants who met the entrance criteria and enrolled in the trial.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole (Once Weekly) | Treatment Discontinuation Rates | All reasons | 47.6 percentage of participants |
| Aripiprazole (Once Weekly) | Treatment Discontinuation Rates | Other than sponsor discontinued study site | 22.4 percentage of participants |