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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De Novo | Experimental | De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. |
|
| Rollover Placebo | Experimental | Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. |
|
| Rollover Aripiprazole | Experimental | Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. | From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs |
| Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 | The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement. | Baseline, Week 8, Week 26, Week 52 |
| Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. | Baseline, Week 8, Week 26, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF) | CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement. |
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Inclusion Criteria - Rollover:
Inclusion Criteria - De Novo:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35203 | United States | ||
| Harmonex Neuroscience |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. | |
| 21813076 | Derived | Marcus RN, Owen R, Manos G, Mankoski R, Kamen L, McQuade RD, Carson WH, Findling RL. Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study. J Clin Psychiatry. 2011 Sep;72(9):1270-6. doi: 10.4088/JCP.09m05933. Epub 2011 Jul 26. |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention (CDC) algorithm for BMI and body weight z-scores | View source |
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109 participants were enrolled in the De Novo arm, 70 in the Rollover Placebo arm, and 174 in the Rollover Aripiprazole arm. 23 participants in the De Novo arm were considered "baseline failures," and did not enter the treatment phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | De Novo | De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint | The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. | Baseline, Week 8, Week 26, Week 52 |
| Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities | Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males) | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
| Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities | Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3 | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
| Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities | Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
| Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities | These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = "to" | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
| Number of Potentially Clinically Relevant Vital Sign Abnormalities | Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm). | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
| Mean Change From Baseline in Patient Weight | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
| Mean Change From Baseline by Time Period in Body Weight Z-Score | The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record). | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
| Mean Change From Baseline in Patient Body Mass Index (BMI) | The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height. | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
| Mean Change From Baseline By Time Period in BMI Z-Score | The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record). | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
| Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| CGI-Improvement Score at Week 52 (Endpoint, LOCF) | CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement. | Week 52 (Endpoint, LOCF) |
| Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement. | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement. | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement. | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement. | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF) | CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement. | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
| Dothan |
| Alabama |
| 36303 |
| United States |
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | United States |
| Univ of Arizona | Tuscon | Arizona | 85724-5002 | United States |
| Clinical Innovations, Inc | Costa Mesa | California | 92626 | United States |
| Peninsula Research Assoc | Rolling Hills Estate | California | 90274 | United States |
| University Of California-Davis Health Science Center | Sacramento | California | 95817 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| Stanford University School Of Medicine | Stanford | California | 94305-5719 | United States |
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
| Offices of Gregory Marsella, MD, PA | Boca Raton | Florida | 33432 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Children's Developmental Center | Winter Park | Florida | 32792 | United States |
| Child Neurology Associates, PC | Atlanta | Georgia | 30342 | United States |
| Institute For Behavioral Medicine | Smyrna | Georgia | 30080-6342 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60608 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
| Cambridge Health Alliance | Cambridge | Massachusetts | 02139 | United States |
| Ladders Clinic | Wellsley | Massachusetts | 02481 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| Children's Hospital Of Michigan | Detroit | Michigan | 48201 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64108-4619 | United States |
| Munroe-Meyer Institute Diagnostic Center | Omaha | Nebraska | 68198-5380 | United States |
| Center for Psychiatry and Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| Children's Specialized Hospital | Toms River | New Jersey | 08755 | United States |
| North Shore - Long Island Jewish Health System | Bethpage | New York | 11714 | United States |
| Seaver and New York Autism Center of Excellence | New York | New York | 10029 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| SUNY at Stony Brook - School of Medicine | Stony Brook | New York | 11794-8790 | United States |
| Mission Hospitals - Mission Children's Clinics | Asheville | North Carolina | 22801 | United States |
| University of NC | Chapel Hill | North Carolina | 27599-7160 | United States |
| Duke Child and Family Study Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0559 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| The Nisonger Center | Columbus | Ohio | 43210 | United States |
| Cutting Edge Research | Oklahoma City | Oklahoma | 73116 | United States |
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15203 | United States |
| UT Medical Group, Department Of Psychiatry | Memphis | Tennessee | 38105 | United States |
| Dallas Pediatric Neurology Associates | Dallas | Texas | 75230 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77007 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| North San Antonio Healthcare Associates | San Antonio | Texas | 78218 | United States |
| Children's National Medical Center | Fairfax | Virginia | 22031 | United States |
| Neuroscience, Inc | Herndon | Virginia | 20170 | United States |
| Monarch Research Associates | Norfolk | Virginia | 23510 | United States |
| Virginia Treatment Center For Children | Richmond | Virginia | 23298 | United States |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98034 | United States |
| Autism Spectrum Treatment and Research Center | Seattle | Washington | 98109 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 21663425 | Derived | Marcus RN, Owen R, Manos G, Mankoski R, Kamen L, McQuade RD, Carson WH, Corey-Lisle PK, Aman MG. Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study. J Child Adolesc Psychopharmacol. 2011 Jun;21(3):229-36. doi: 10.1089/cap.2009.0121. |
| FG001 | Rollover Placebo | Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. |
| FG002 | Rollover Aripiprazole | Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. |
| FG003 | Total |
| Safety Population |
|
| Efficacy Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | De Novo | As previously described in Participant Flow |
| BG001 | Rollover Placebo | As previously described in Participant Flow |
| BG002 | Rollover Aripiprazole | As previously described in Participant Flow |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. | Safety Population | Posted | Number | Participants | From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 | The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement. | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 26, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 26, Week 52 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint | The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 26, Week 52 |
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| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities | Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males) | Safety Sample | Posted | Number | Participants | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
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| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities | Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3 | Safety Sample | Posted | Number | Participants | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
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| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities | Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL | Safety Sample | Posted | Number | Participants | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
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| Primary | Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities | These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = "to" | Safety Sample | Posted | Number | Participants | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 |
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| Primary | Number of Potentially Clinically Relevant Vital Sign Abnormalities | Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm). | Safety Sample | Posted | Number | Participants | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
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| Primary | Mean Change From Baseline in Patient Weight | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | kg | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
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| Primary | Mean Change From Baseline by Time Period in Body Weight Z-Score | The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record). | Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations. | Posted | Mean | Standard Deviation | Standard Deviations away from Population | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
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| Primary | Mean Change From Baseline in Patient Body Mass Index (BMI) | The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height. | Safety Sample: Endpoint - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | kg/m2 | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
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| Primary | Mean Change From Baseline By Time Period in BMI Z-Score | The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record). | Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations. | Posted | Mean | Standard Deviation | Standard Deviations away from Population | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
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| Secondary | Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF) | CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement. | Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| Secondary | CGI-Improvement Score at Week 52 (Endpoint, LOCF) | CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement. | Efficacy Sample. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. | Posted | Mean | Standard Deviation | units on a scale | Week 52 (Endpoint, LOCF) |
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| Secondary | Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement | Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| Secondary | Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement. | Efficacy Sample, LOCF.The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| Secondary | Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement. | Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| Secondary | Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement. | Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| Secondary | Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF) | The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement. | Efficacy Sample, LOCF | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| Secondary | Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF) | CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement. | Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 96 patients did not have post-baseline evaluations for CY-BOCS, and were excluded from the efficacy analyses. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (Baseline), Week 52 (Endpoint, LOCF) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | De Novo | 3 | 86 | 73 | 86 | |||
| EG001 | Roll Over Aripiprazole | 5 | 174 | 136 | 174 | |||
| EG002 | Roll Over Placebo | 1 | 70 | 61 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGGRESSION | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| IMPULSIVE BEHAVIOUR | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12 | Systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| PHARYNGOTONSILLITIS | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WEIGHT INCREASED | Investigations | MedDRA 12 | Systematic Assessment |
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| TIC | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| AGGRESSION | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| DROOLING | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| LETHARGY | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| DYSKINESIA | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| EAR INFECTION | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| ENURESIS | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
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| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 12 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D001526 | Behavioral Symptoms |
| D000066553 | Problem Behavior |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D002652 | Child Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| 13 to 17 years |
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| Male |
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| Treatment-Emergent SAEs |
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| Treatment-Emergent AEs |
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| Treatment-Emergent AEs Leading to Discontinuation |
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| Treatment-Emergent EPS-Related AEs |
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| Total |
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| Participants |
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| Participants |
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| OG003 |
| Total |
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| OG002 |
| Rollover Aripiprazole |
As previously described in Participant Flow |
| OG003 | Total |
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| Units | Counts |
|---|
| Participants |
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| Rollover Aripiprazole |
As previously described in Participant Flow |
| OG003 | Total |
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| Units | Counts |
|---|---|
| Participants |
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As previously described in Participant Flow
| OG003 | Total |
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As previously described in Participant Flow
| OG003 | Total |
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As previously described in Participant Flow
| OG003 | Total |
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As previously described in Participant Flow
| OG003 | Total |
|
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As previously described in Participant Flow |
| OG003 | Total |
|
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