Back to resultsA Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Primary Purpose
Autistic Disorder in Children and Adolescents
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Risperidone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder in Children and Adolescents focused on measuring Autistic disorder in children and adolescents, Risperidone (R064766), Children, Adolescents, Irritability, Autistic disorder
Eligibility Criteria
Inclusion Criteria:
- Diagnostic for autistic disorder
- A Clinical Global Impression - Severity (CGI-S) score of =>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =>18
- Patients with mental age of >18 months as measured by appropriate developmental or mental scales
- Patients who have an appropriate caregiver, eg, parent or study-site personnel, who is able to observe the patient's condition, provide information, and evaluate the patient's response appropriately
Exclusion Criteria:
- Patients with previous or current psychotic disorder (eg, schizophrenia, bipolar disorder, or other psychiatric disorders) or with pervasive developmental disorder not otherwise specified, Asperger's disorder, Rett's disorder, pediatric destructive behavior disorder, or substance dependence
- Patients with a clinically significant endocrine, metabolic, cardiac, hepatic, renal, or pulmonary disorder, or hypertension
- Weight of <15 kg at the time of screening and baseline
- Patients with QTc>450 msec in the standard 12-lead electrocardiogram (ECG) at the time of screening
- Patients with known hypersensitivity to risperidone or paliperidone
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Risperidone
Placebo
Arm Description
Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
Subjects will receive placebo matching with risperidone orally up to 8 weeks.
Outcomes
Primary Outcome Measures
The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores
The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
Secondary Outcome Measures
The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase
The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase
The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the open-label-phase
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of the double-blind phase and open-label-phase
The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.
The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of open-label-phase
The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.
The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the double-blind phase
The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).
The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the open label-phase
The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).
The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the double-blind phase
The PSQ evaluates the caregiver's satisfaction with the study drug.
The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the open label-phase
The PSQ evaluates the caregiver's satisfaction with the study drug.
Full Information
NCT ID
NCT01624675
First Posted
June 19, 2012
Last Updated
October 13, 2015
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01624675
Brief Title
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Official Title
A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.
Detailed Description
This is a randomized (the drug is assigned by chance), 8-week, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), flexible-dose, multicenter study. It will be followed by a 48-week, flexible-dose, open-label (all people know the identity of the intervention) extension, to evaluate the efficacy and safety of risperidone in children and adolescents with a diagnosis of autistic disorder (severe form of pervasive developmental disorder) who have associated irritability. The study consists of up to 2-week screening phase, an 8-week double-blind phase, a 48-week open-label phase, and a 1-week follow-up phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder in Children and Adolescents
Keywords
Autistic disorder in children and adolescents, Risperidone (R064766), Children, Adolescents, Irritability, Autistic disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risperidone
Arm Type
Experimental
Arm Description
Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo matching with risperidone orally up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo matching with risperidone orally up to 8 weeks.
Primary Outcome Measure Information:
Title
The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores
Description
The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase
Description
The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
Time Frame
Baseline, Week 2, Week 4, Week 6
Title
The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase
Description
The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
Title
The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase
Description
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
Time Frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
Title
The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the open-label-phase
Description
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
Time Frame
Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
Title
The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of the double-blind phase and open-label-phase
Description
The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.
Time Frame
Baseline, Week 4, Week 8
Title
The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of open-label-phase
Description
The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.
Time Frame
Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
Title
The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the double-blind phase
Description
The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
Title
The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the open label-phase
Description
The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
Title
The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the double-blind phase
Description
The PSQ evaluates the caregiver's satisfaction with the study drug.
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
Title
The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the open label-phase
Description
The PSQ evaluates the caregiver's satisfaction with the study drug.
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic for autistic disorder
A Clinical Global Impression - Severity (CGI-S) score of =>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =>18
Patients with mental age of >18 months as measured by appropriate developmental or mental scales
Patients who have an appropriate caregiver, eg, parent or study-site personnel, who is able to observe the patient's condition, provide information, and evaluate the patient's response appropriately
Exclusion Criteria:
Patients with previous or current psychotic disorder (eg, schizophrenia, bipolar disorder, or other psychiatric disorders) or with pervasive developmental disorder not otherwise specified, Asperger's disorder, Rett's disorder, pediatric destructive behavior disorder, or substance dependence
Patients with a clinically significant endocrine, metabolic, cardiac, hepatic, renal, or pulmonary disorder, or hypertension
Weight of <15 kg at the time of screening and baseline
Patients with QTc>450 msec in the standard 12-lead electrocardiogram (ECG) at the time of screening
Patients with known hypersensitivity to risperidone or paliperidone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Fuchu
Country
Japan
City
Fukui
Country
Japan
City
Hirakata
Country
Japan
City
Ichikawa
Country
Japan
City
Kanzaki
Country
Japan
City
Kobe
Country
Japan
City
Kodaira
Country
Japan
City
Kurashiki
Country
Japan
City
Neyagawa
Country
Japan
City
Okayama
Country
Japan
City
Sakai
Country
Japan
City
Shimotsuke
Country
Japan
City
Tokyo
Country
Japan
City
Toyama
Country
Japan
City
Tsuyama
Country
Japan
City
Tsu
Country
Japan
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3545&filename=CR100877_CSR.pdf
Description
A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents with Irritability Associated with Autistic Disorder
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
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