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NCT03664232 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT03664232: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03664232 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664232, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study 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).
Primary Outcome
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 commu
Interventions
- DRUG Placebo
- DRUG JNJ-42165279
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2022-10-28 |
| Phase | Phase 2 |
What the finished NCT03664232 record still lists
NCT03664232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03664232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03664232 about?
NCT03664232 is a clinical study titled "A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder". 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).
What is the current status of trial NCT03664232?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2018-11-07. Estimated completion is 2022-10-28.
What interventions are being tested in trial NCT03664232?
The interventions under investigation include: Placebo (DRUG), JNJ-42165279 (DRUG).
Who is sponsoring clinical trial NCT03664232?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03664232's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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