Back to resultsA Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (Envision)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-42165279
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) (minimum score of 8 [autism spectrum])
- Otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Have a composite score on Kaufman Brief Intelligence Test, Second Edition (KBIT-2) of at least 60
- Must live with a parent or primary caregiver or, if not, during each week he/she must either (A) spend at least 3 hours a day for at least 4 days or, (B) spend the weekend with a parent or primary caregiver
- Any pharmacologic, diet, or behavioral intervention for ASD must have begun at least 1 month prior to the baseline visit and continue unchanged through the treatment period, or have ended at least 1 month prior to the baseline visit
- Must be able to swallow the study medication whole and self-administer medication if living independently or have a parent or caregiver be able to administer medication
- Must agree to abide by the birth control requirements during the study and for 3 months after the last dose
Exclusion Criteria:
- Current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
- Use of a drug with moderate/strong cytochrome P450 (CYP)3A4 inhibiting or inducing properties at, or prior to, screening that is not discontinued at least within 1 month prior to Day 1
- History of drug or alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (except if related to current treatment)
- Currently taking or has taken within the past month recreational or medically prescribed cannabis
Sites / Locations
- Harmonex Neuroscience Research
- Southwest Autism Research and Resource Center
- NRC Research Institute
- New York Presbyterian Hospital
- Nathan Kline Institute
- Cincinnati Children's Hospital Medical Center
- Cutting Edge Research Group
- BioBehavioral Research of Austin, PC
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JNJ-42165279
Placebo
Arm Description
Participants will self-administer 25 milligram (mg) JNJ-42165279 tablets orally twice daily for 12 weeks.
Participants will self-administer matching placebo tablets orally twice daily for 12 weeks.
Outcomes
Primary Outcome Measures
Change from Baseline in the Autism Behavior Inventory (ABI) Core Domain Score to Day 85
Change from baseline in the ABI core domain score will be reported. ABI is a 62-item questionnaire completed on a web/mobile application or on paper. It is part of the Janssen Autism Knowledge Engine (JAKE), a research tool that tracks outcomes in Autism Spectrum Disorder (ASD). Each ABI item is answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior) or frequency (how often a particular behavior occurs). Each item is rated on a scale of 0-3 (never to very often [frequency] or not at all to without help [quality]). The ABI Core Domain Score is calculated as the sum of the scores in the Social Communication Domain and the Repetitive/Restrictive Behavior Domain divided by the total number of items in these 2 domains.
Change from Baseline in ABI Social Communication Domain Score to Day 85
Change from baseline in the ABI social communication domain score will be reported. Each item is rated on a scale of 0-3 (never to very often [frequency] or not at all to without help [quality]). The ABI social communication domain score is calculated as the sum of the scores in the social communication domain divided by the total number of items in this domain.
Change from Baseline in ABI Repetitive/Restrictive Behavior (RRB) Domain Score to Day 85
Change from baseline in the ABI RRB domain score will be reported. Each item is rated on a scale of 0-3 (never to very often). The ABI RRB domain score is calculated as the sum of the scores in the RRB domain divided by the total number of items in this domain.
Secondary Outcome Measures
Change from Baseline in the ABI Mood and Anxiety Domain Score to Day 85
Change from baseline in the ABI mood and anxiety domain score will be reported. The ABI mood and anxiety domain score is calculated as the sum of the scores in the mood and anxiety domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often).
Change from Baseline in the ABI Challenging Behavior Domain Score
Change from baseline in the ABI challenging behavior domain score will be reported. The ABI challenging behavior domain score is calculated as the sum of the scores in the challenging behavior domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often).
Change from Baseline in the ABI Self-Regulation Domain Score
Change from baseline in the ABI self-regulation domain score will be reported. The ABI self-regulation domain score is calculated as the sum of the scores in the self-regulation domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often).
Change from Baseline in the Aberrant Behavior Checklist (ABC) Subscales
Change from baseline in the ABC subscales will be reported. The ABC is a 58-item behavior rating scale used to measure behavior problems across 5 subscales: Irritability, Lethargy (Social Withdrawal), Stereotypy, Hyperactivity, Inappropriate Speech. Items are rated on a 4-point scale (ranging from 0 [not at all a problem] to 3 [the problem is severe in degree]).
Change from Baseline in the Autism Behavior Inventory-Short Form (ABI-S) Scale Domains
Change from baseline in the ABI-S scale domains will be reported. ABI-S is the shorter version of the ABI. It consists of 24 items across 5 areas, social communication, RRB, mood and anxiety, challenging behavior, and self-regulation. Each ABI-S domain score is calculated as the sum of the scores in the ABI-S domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often [frequency] or not at all to without help [quality]).
Change from Baseline in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains
Change from baseline in the ABI-C domains will be reported. The ABI-C is designed to capture the behaviors of a person with ASD that have occurred over the past week. There are 14 items across each of the 5 domains (social communication, restrictive behaviors, mood and anxiety, self regulation and challenging behavior). The clinician rates the severity of behaviors and level of impairment on a scale of 1 (none) to 7 (very severe).
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Scale Score
Change from baseline in the CGI-S scale score will be reported. The CGI-S rating scale is a global assessment that measures the clinician's impression of the severity of illness of the participant. A rating scale of 1-7 is used, with 1="normal, not at all ill" and 7="among the most extremely ill".
Change from Baseline in the Repetitive Behavior Scale - Revised (RBS-R) Scale Score
Change from baseline in the RBS-R scale score will be reported. The RBS-R is a 43-item rating scale to indicate occurrence of repetitive behaviors and degree to which a behavior is a problem on a range between 0 to 3, where 0 = behavior does not occur and 3 = behavior occurs and is a severe problem.
Change from Baseline in the Zarit Burden Interview (ZBI) Scale Score
Change from baseline in the ZBI scale score will be reported. The ZBI short version scale consists of 22 items designed to assess the psychological burden experienced by a caregiver. Responses range from 0-4, where 0 = never and 4 = nearly always.
Change from Baseline in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score
Change from baseline in the CASI-Anx scale score will be reported. CASI-Anx is a 21-point anxiety subscale of the full CASI. Responses will range from 0 to 3, where 0 = never and 3 = very often.
Change from Baseline in the Social Responsiveness Scale 2 (SRS-2) Score
Change from baseline in the SRS-2 scale score will be reported. The SRS-2 is a 65-item scale that measures social impairment and includes 5 subscales. Responses range from 1 to 4, where 1 = Not true and 4 = almost always true.
Change from Baseline in the Caregiver Global Impression of Severity (Caregiver GI-S)
Change from baseline in the Caregiver GI-S scale score will be reported. The Caregiver GI-S is a single-item instrument that asks caregivers to rate their overall impression of the severity of their child's ASD symptoms. Responses range from 1 to 7, where 1 = None and 7 = Severe.
Caregiver Assessment of Treatment Score
The Caregiver Assessment of Treatment is a 3-item questionnaire. Caregivers rate their global impression of improvement in their child's autism, whether there was improvement in specific symptoms, and their interest in having their child continue the study medication. One item uses a scale of 1 (very much improved) to 7 (very much worse), another item includes a Yes/No checklist, and another item uses a scale of 1 (not at all interested) to 5 (extremely interested).
Self Global Impression of Improvement (Self GI-I) Score
The participant will be asked to give his/her impression of overall improvement in ASD symptoms using a single-item instrument, the Self GI-I. Responses will range from 1 to 7, where 1 = Very much better and 7 = Very much worse.
Clinical Global Impression-Improvement (CGI-I)
The CGI-I is a single-item instrument that measures the clinician's global impression of improvement in the participant from the initiation of treatment. A 7-point scale is used, with 1=very much improved and 7=very much worse.
Full Information
NCT ID
NCT03664232
First Posted
September 7, 2018
Last Updated
October 16, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03664232
Brief Title
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
Acronym
Envision
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Subjects With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-42165279
Arm Type
Experimental
Arm Description
Participants will self-administer 25 milligram (mg) JNJ-42165279 tablets orally twice daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will self-administer matching placebo tablets orally twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-42165279
Intervention Description
Participants will receive 25 mg JNJ-42165279 orally twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a matching placebo orally twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in the Autism Behavior Inventory (ABI) Core Domain Score to Day 85
Description
Change from baseline in the ABI core domain score will be reported. ABI is a 62-item questionnaire completed on a web/mobile application or on paper. It is part of the Janssen Autism Knowledge Engine (JAKE), a research tool that tracks outcomes in Autism Spectrum Disorder (ASD). Each ABI item is answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior) or frequency (how often a particular behavior occurs). Each item is rated on a scale of 0-3 (never to very often [frequency] or not at all to without help [quality]). The ABI Core Domain Score is calculated as the sum of the scores in the Social Communication Domain and the Repetitive/Restrictive Behavior Domain divided by the total number of items in these 2 domains.
Time Frame
Baseline up to Day 85
Title
Change from Baseline in ABI Social Communication Domain Score to Day 85
Description
Change from baseline in the ABI social communication domain score will be reported. Each item is rated on a scale of 0-3 (never to very often [frequency] or not at all to without help [quality]). The ABI social communication domain score is calculated as the sum of the scores in the social communication domain divided by the total number of items in this domain.
Time Frame
Baseline up to Day 85
Title
Change from Baseline in ABI Repetitive/Restrictive Behavior (RRB) Domain Score to Day 85
Description
Change from baseline in the ABI RRB domain score will be reported. Each item is rated on a scale of 0-3 (never to very often). The ABI RRB domain score is calculated as the sum of the scores in the RRB domain divided by the total number of items in this domain.
Time Frame
Baseline up to Day 85
Secondary Outcome Measure Information:
Title
Change from Baseline in the ABI Mood and Anxiety Domain Score to Day 85
Description
Change from baseline in the ABI mood and anxiety domain score will be reported. The ABI mood and anxiety domain score is calculated as the sum of the scores in the mood and anxiety domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often).
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the ABI Challenging Behavior Domain Score
Description
Change from baseline in the ABI challenging behavior domain score will be reported. The ABI challenging behavior domain score is calculated as the sum of the scores in the challenging behavior domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often).
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the ABI Self-Regulation Domain Score
Description
Change from baseline in the ABI self-regulation domain score will be reported. The ABI self-regulation domain score is calculated as the sum of the scores in the self-regulation domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often).
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Aberrant Behavior Checklist (ABC) Subscales
Description
Change from baseline in the ABC subscales will be reported. The ABC is a 58-item behavior rating scale used to measure behavior problems across 5 subscales: Irritability, Lethargy (Social Withdrawal), Stereotypy, Hyperactivity, Inappropriate Speech. Items are rated on a 4-point scale (ranging from 0 [not at all a problem] to 3 [the problem is severe in degree]).
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Autism Behavior Inventory-Short Form (ABI-S) Scale Domains
Description
Change from baseline in the ABI-S scale domains will be reported. ABI-S is the shorter version of the ABI. It consists of 24 items across 5 areas, social communication, RRB, mood and anxiety, challenging behavior, and self-regulation. Each ABI-S domain score is calculated as the sum of the scores in the ABI-S domain divided by the total number of items in this domain. Each item is rated on a scale of 0-3 (never to very often [frequency] or not at all to without help [quality]).
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains
Description
Change from baseline in the ABI-C domains will be reported. The ABI-C is designed to capture the behaviors of a person with ASD that have occurred over the past week. There are 14 items across each of the 5 domains (social communication, restrictive behaviors, mood and anxiety, self regulation and challenging behavior). The clinician rates the severity of behaviors and level of impairment on a scale of 1 (none) to 7 (very severe).
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Scale Score
Description
Change from baseline in the CGI-S scale score will be reported. The CGI-S rating scale is a global assessment that measures the clinician's impression of the severity of illness of the participant. A rating scale of 1-7 is used, with 1="normal, not at all ill" and 7="among the most extremely ill".
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Repetitive Behavior Scale - Revised (RBS-R) Scale Score
Description
Change from baseline in the RBS-R scale score will be reported. The RBS-R is a 43-item rating scale to indicate occurrence of repetitive behaviors and degree to which a behavior is a problem on a range between 0 to 3, where 0 = behavior does not occur and 3 = behavior occurs and is a severe problem.
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Zarit Burden Interview (ZBI) Scale Score
Description
Change from baseline in the ZBI scale score will be reported. The ZBI short version scale consists of 22 items designed to assess the psychological burden experienced by a caregiver. Responses range from 0-4, where 0 = never and 4 = nearly always.
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score
Description
Change from baseline in the CASI-Anx scale score will be reported. CASI-Anx is a 21-point anxiety subscale of the full CASI. Responses will range from 0 to 3, where 0 = never and 3 = very often.
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Social Responsiveness Scale 2 (SRS-2) Score
Description
Change from baseline in the SRS-2 scale score will be reported. The SRS-2 is a 65-item scale that measures social impairment and includes 5 subscales. Responses range from 1 to 4, where 1 = Not true and 4 = almost always true.
Time Frame
Baseline up to Day 85
Title
Change from Baseline in the Caregiver Global Impression of Severity (Caregiver GI-S)
Description
Change from baseline in the Caregiver GI-S scale score will be reported. The Caregiver GI-S is a single-item instrument that asks caregivers to rate their overall impression of the severity of their child's ASD symptoms. Responses range from 1 to 7, where 1 = None and 7 = Severe.
Time Frame
Baseline up to Day 85
Title
Caregiver Assessment of Treatment Score
Description
The Caregiver Assessment of Treatment is a 3-item questionnaire. Caregivers rate their global impression of improvement in their child's autism, whether there was improvement in specific symptoms, and their interest in having their child continue the study medication. One item uses a scale of 1 (very much improved) to 7 (very much worse), another item includes a Yes/No checklist, and another item uses a scale of 1 (not at all interested) to 5 (extremely interested).
Time Frame
Day 85
Title
Self Global Impression of Improvement (Self GI-I) Score
Description
The participant will be asked to give his/her impression of overall improvement in ASD symptoms using a single-item instrument, the Self GI-I. Responses will range from 1 to 7, where 1 = Very much better and 7 = Very much worse.
Time Frame
Day 85
Title
Clinical Global Impression-Improvement (CGI-I)
Description
The CGI-I is a single-item instrument that measures the clinician's global impression of improvement in the participant from the initiation of treatment. A 7-point scale is used, with 1=very much improved and 7=very much worse.
Time Frame
Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Autism Spectrum Disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) (minimum score of 8 [autism spectrum])
Otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
Have a composite score on Kaufman Brief Intelligence Test, Second Edition (KBIT-2) of at least 60
Must live with a parent or primary caregiver or, if not, during each week he/she must either (A) spend at least 3 hours a day for at least 4 days or, (B) spend the weekend with a parent or primary caregiver
Any pharmacologic, diet, or behavioral intervention for ASD must have begun at least 1 month prior to the baseline visit and continue unchanged through the treatment period, or have ended at least 1 month prior to the baseline visit
Must be able to swallow the study medication whole and self-administer medication if living independently or have a parent or caregiver be able to administer medication
Must agree to abide by the birth control requirements during the study and for 3 months after the last dose
Exclusion Criteria:
Current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
Use of a drug with moderate/strong cytochrome P450 (CYP)3A4 inhibiting or inducing properties at, or prior to, screening that is not discontinued at least within 1 month prior to Day 1
History of drug or alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (except if related to current treatment)
Currently taking or has taken within the past month recreational or medically prescribed cannabis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Southwest Autism Research and Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nathan Kline Institute
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
BioBehavioral Research of Austin, PC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
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