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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Active Abilify |
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| A2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score | The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Clinical Global Impressions Improvement Scale (CGI-I) Score | The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marsella, Gregory | Boca Raton | Florida | 33432 | United States | ||
| Child Neurology Associates, Pc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19948625 | Background | Owen R, Sikich L, Marcus RN, Corey-Lisle P, Manos G, McQuade RD, Carson WH, Findling RL. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. 2009 Dec;124(6):1533-40. doi: 10.1542/peds.2008-3782. | |
| 24138011 | Derived | Mankoski R, Stockton G, Manos G, Marler S, McQuade R, Forbes RA, Marcus R. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):572-6. doi: 10.1089/cap.2012.0075. |
| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | oral placebo once daily (QD) |
| FG001 | Aripiprazole | oral aripiprazole 2 to 15 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Tablets, Oral, once daily, 8 weeks |
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| Week 8 |
| Number of Participants With Response at Week 8 | Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint | Week 8 |
| Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) | CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement. | Week 8 |
| Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores | Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement | Week 8 |
| Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) | A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement. | Week 8 |
| Summary of Safety | Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation | continuous throughout the study |
| Change From Baseline in Body Weight | Adjusted mean change (Week 8 - baseline) in body weight | Week 8 |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| Center For Psychiatry And Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| Suny - Stony Brook School Of Medicine | Stony Brook | New York | 11794 | United States |
| Univ Of Nc | Chapel Hill | North Carolina | 27599 | United States |
| Ut Medical Group | Memphis | Tennessee | 38105 | United States |
| Red Oak Psychiatry Associates, Pa | Houston | Texas | 77090 | United States |
| 21731831 | Derived | Robb AS, Andersson C, Bellocchio EE, Manos G, Rojas-Fernandez C, Mathew S, Marcus R, Owen R, Mankoski R. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric subjects (6-17 years old):results from a pooled analysis of 2 studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01008. doi: 10.4088/PCC.10m01008gry. |
| 20973712 | Derived | Aman MG, Kasper W, Manos G, Mathew S, Marcus R, Owen R, Mankoski R. Line-item analysis of the Aberrant Behavior Checklist: results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):415-22. doi: 10.1089/cap.2009.0120. |
| Otsuka Clinical Trial Transparency | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | oral placebo once daily (QD) |
| BG001 | Aripiprazole | oral aripiprazole 2 to 15 mg QD |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race, Customized | Number | participants |
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| Ethnicity, Customized | Number | participants |
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| Weight Group | Number | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/cm2 |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| 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 | Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score | The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement. | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Mean Clinical Global Impressions Improvement Scale (CGI-I) Score | The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse). | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Number of Participants With Response at Week 8 | Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | Posted | Number | participant | Week 8 |
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| Secondary | Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) | CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement. | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores | Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | Posted | Mean | Standard Error | units of a scale | Week 8 |
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| Secondary | Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) | A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement. | Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Secondary | Summary of Safety | Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation | Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Data set is LOCF. | Posted | Number | participants | continuous throughout the study |
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| Secondary | Change From Baseline in Body Weight | Adjusted mean change (Week 8 - baseline) in body weight | Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Includes all participants with weight measurement at baseline and timepoint. Data set is LOCF. | Posted | Mean | Standard Error | kilograms | Week 8 |
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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) |
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| EG000 | Aripiprazole | 0 | 47 | 38 | 47 | |||
| EG001 | Placebo | 0 | 50 | 29 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INSOMNIA | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
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| AGGRESSION | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| DROOLING | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 11 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 11 | Systematic Assessment |
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| ENURESIS | Renal and urinary disorders | MedDRA 11 | Systematic Assessment |
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| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 11 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 11 | 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 | |
|---|---|---|---|---|
| Clinical Transparency | Otsuka | 1-800-441-6763 | SMB_ClinicalTranspa@otsuka-us.com |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000066553 | Problem Behavior |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |
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| 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 |
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| Title | Measurements |
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| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Other |
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| Not Hispanic/Latino |
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| ≥40 kilograms |
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