Trial · NCT03664232
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
NCT03664232, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2025-04-23
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ConductScience Library. A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder. Trials, record NCT03664232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03664232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
- NCT number
- NCT03664232
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Autism Spectrum Disorder
- Interventions
- JNJ-42165279, Placebo
- First posted
- 2018-09-10
- Last updated
- 2025-04-23
- Results first posted
- 2025-04-23
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) | Baseline (Day 1) to Day 85 | ABI:62-item questionnaire to track outcomes in autism spectrum disorder (ASD). Each item was answered on 1 of 2 possible dimensions: quality (how well person carries out particular behavior; 1 to 13 items) or frequency (how often particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score=severe symptoms/more frequency. ABI core domain score was from 2 domains: social communication (23 items; 3 sub-domains) and repetitive/restrictive behavior (RRB;15 items; 4 sub-domains). Domain and sub-domain scores: calculated as average of non-missing items (ie, sum of all non-missing items divided by number of non-missing items); scores ranged from 0 to 3, higher scores=more severe symptoms of ASD. ABI core domain score=sum of social communication and RRB domain scores divided by total number of items in these 2 domains. Negative changes in ABI core domain score=improvement. |
| Primary | Change From Baseline to Day 85 in the ABI Social Communication Domain Score | Baseline (Day 1) to Day 85 | ABI was 62-item questionnaire completed on a web/mobile application or on paper. It tracks outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. The ABI social communication domain score consisted of 23 items; with 3 sub-domains. The domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). For both domains and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. Negative change in score indicates improvement. |
| Primary | Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score | Baseline (Day 1) to Day 85 | ABI is 62-item questionnaire completed on a web/mobile application or on paper. It tracks outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. The ABI RRB domain score consisted of 15 items; with 3 sub-domains. The domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). For both domains and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. Negative change in score indicates improvement. |
| Primary | Change From Baseline to Day 85 in the Social Responsiveness Scale 2 (SRS-2) Total T-Score | Baseline (Day 1) to Day 85 | SRS-2: 65-item scale measured extent of autistic social impairment and included 5 subscales: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behavior. Each of 65 items had 4 responses: not true, sometimes true, often true, and almost always true. Scoring value for each item was 0 to 3. If a response to an item was missing, then pre-defined median value for item (0 or 1) was imputed. SRS-2 was not scored if 7 or more item responses were missed. Total raw score was sum of item response values. Each subscale was obtained by adding response values and converted total raw score to standardized T-score based on gender and rater (parent or caregiver). Total T-score was categorized: within normal limits (\<=59), mild (60 to 65), moderate (66 to 75) and severe (\>=76). For total score T-score, higher scores=more severe symptoms. SRS T-score had mean of 50 and standard deviation of 10. Negative changes in T-scores=improvement. |
| Secondary | Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | Baseline (Day 1) to Day 85 | ABI was 62-item questionnaire to track outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. ABI mood and anxiety domain had 9 items with 5 sub-domains. ABI mood and anxiety domain and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. Domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). Negative changes in ABI mood and anxiety domain score indicated improvement. |
| Secondary | Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score | Baseline (Day 1) to Day 85 | ABI was 62-item questionnaire to track outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. ABI challenging behavior domain had 7 items with 4 sub-domains. ABI challenging behavior domain and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. The domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). Negative changes in ABI challenging behavior domain score indicated improvement. |
| Secondary | Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score | Baseline (Day 1) to Day 85 | ABI was 62-item questionnaire to track outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. ABI self-regulation domain had 8 items with 2 sub-domains. ABI self-regulation domain and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. The domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). Negative changes in ABI self-regulation domain score indicated improvement. |
| Secondary | Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores | Baseline (Day 1) to Day 85 | The ABC was 58-item behavior rating scale used to measure behavior problems across 5 subscales: irritability (15 items), lethargy (social withdrawal; 16 items), stereotypic behavior (7 items), hyperactivity/ noncompliance (16 items), and inappropriate speech (4 items). Items were rated on a 4-point scale score ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The total subscale scores ranged from 0 to 45, 0 to 48, 0 to 21, 0 to 48 and 0 to 12 for irritability, lethargy (social withdrawal), stereotypic behavior, hyperactivity, and inappropriate speech respectively. The higher scores indicating more severe behavior problems. Negative change in score indicated improvement. |
| Secondary | Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores | Baseline (Day 1) to Day 71 | The ABI-S was the shorter version of ABI. It consists of 24 items across 5 areas: challenging behavior (3 items), mood and anxiety (5 items), restrictive behaviors (7 items), social communication (6 items), and self-regulation (3 items). Each item was 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 ABI-S domain score was calculated as the sum of the scores in the ABI-S domain divided by the total number of items in this domain. Each item was rated on scales of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. The total subscale scores ranged from 0 to 9, 0 to 15, 0 to 21, 0 to 18, and 0 to 9, for challenging behavior, mood and anxiety, restrictive behaviors, social communication, and self-regulation respectively. Lower score indicated better performance. Negative change in score indicates improvement. |
| Secondary | Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores | Baseline (Day 1) to Day 85 | The ABI-C covers the domains of ABI and was intended for completion by the clinician following an interview with caregiver and observation or interview with the individual with ASD, as appropriate. The ABI-C was designed to capture the behaviors of a person with ASD that have occurred over the past week. There were 14 items across each of the 5 domains: challenging behavior (2 items), mood and anxiety (2 items), restrictive behaviors (5 items), social communication (3 items), and self-regulation (2 items). The clinician rates the severity of behaviors or level of impairment on a scale of 1 (no impairment) to 7 (very severe difficulties) with a higher score indicating more severe symptoms of ASD. Total subscale scores ranged from 0 to 14, 0 to 14, 0 to 35, 0 to 21 and 0 to 14, for challenging behavior, mood and anxiety, restrictive behaviors, social communication and self-regulation respectively. Lower score indicated better performance. Negative change in score indicates improvement. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) | Baseline (Day 1) to Day 85 | The full analysis set twice daily (FAS-BID) included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study statistical analysis plan (SAP), data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline to Day 85 in the ABI Social Communication Domain Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores | Baseline (Day 1) to Day 71 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Clinical Global Impression-Severity (CGI-S) Scale Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group268
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) | Placebo BID | -0.20 | Standard Deviation 0.400 | Score on a scale | |
| Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) | JNJ-42165279 25 mg BID | -0.26 | Standard Deviation 0.274 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Social Communication Domain Score | Placebo BID | -0.22 | Standard Deviation 0.379 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Social Communication Domain Score | JNJ-42165279 25 mg BID | -0.27 | Standard Deviation 0.332 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score | Placebo BID | -0.17 | Standard Deviation 0.525 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score | JNJ-42165279 25 mg BID | -0.23 | Standard Deviation 0.299 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | Placebo QD | -0.30 | Standard Deviation 0.408 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | Placebo BID | -0.23 | Standard Deviation 0.622 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | JNJ-42165279 25 mg QD | -0.19 | Standard Deviation 0.551 | Score on a scale | |
| Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | JNJ-42165279 25 mg BID | -0.26 | Standard Deviation 0.552 | Score on a scale |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo QD | 7 | |
| Overall Study | STARTED | Placebo BID | 31 | |
| Overall Study | STARTED | JNJ-42165279 25 mg QD | 8 | |
| Overall Study | STARTED | JNJ-42165279 25 mg BID | 32 | |
| Overall Study | Treated | Placebo QD | 7 | |
| Overall Study | Treated | Placebo BID | 30 | |
| Overall Study | Treated | JNJ-42165279 25 mg QD | 8 | |
| Overall Study | Treated | JNJ-42165279 25 mg BID | 32 | |
| Overall Study | COMPLETED | Placebo QD | 7 | |
| Overall Study | COMPLETED | Placebo BID | 26 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Early Repolarisation Syndrome | Cardiac disorders | Placebo QD | 1 | 7 | |
| other | Early Repolarisation Syndrome | Cardiac disorders | Placebo BID | 0 | 30 | |
| other | Early Repolarisation Syndrome | Cardiac disorders | JNJ-42165279 25 mg QD | 0 | 8 | |
| other | Early Repolarisation Syndrome | Cardiac disorders | JNJ-42165279 25 mg BID | 0 | 32 | |
| other | Motion Sickness | Ear and labyrinth disorders | Placebo QD | 0 | 7 | |
| other | Motion Sickness | Ear and labyrinth disorders | Placebo BID | 0 | 30 | |
| other | Motion Sickness | Ear and labyrinth disorders | JNJ-42165279 25 mg QD | 1 | 8 | |
| other | Motion Sickness | Ear and labyrinth disorders | JNJ-42165279 25 mg BID | 0 | 32 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo QD | 0 | 7 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo BID | 0 | 30 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo QD | 0 | 7 |
| Total, all-cause mortality | Placebo BID | 0 | 31 |
| Total, all-cause mortality | JNJ-42165279 25 mg QD | 0 | 8 |
| Total, all-cause mortality | JNJ-42165279 25 mg BID | 0 | 32 |
| Total, other adverse events | Placebo QD | 5 | 7 |
| Total, other adverse events | Placebo BID | 7 | 30 |
| Total, other adverse events | JNJ-42165279 25 mg QD | 7 | 8 |
| Total, other adverse events | JNJ-42165279 25 mg BID | 3 | 32 |
| Total, serious adverse events | Placebo QD | 0 | 7 |
| Total, serious adverse events | Placebo BID | 0 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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