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JNJ-42165279 for Autism Spectrum Disorder (Envision Trial)

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 85
Awards & highlights

Envision Trial Summary

This trial will study if JNJ-42165279, compared to placebo, can improve symptoms of Autism Spectrum Disorder over 12 weeks of treatment.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Envision Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in ABI Repetitive/Restrictive Behavior (RRB) Domain Score to Day 85
Change from Baseline in ABI Social Communication Domain Score to Day 85
Change from Baseline in the Autism Behavior Inventory (ABI) Core Domain Score to Day 85
Secondary outcome measures
Caregiver Assessment of Treatment Score
Change from Baseline in the ABI Challenging Behavior Domain Score
Change from Baseline in the ABI Mood and Anxiety Domain Score to Day 85
+12 more

Side effects data

From 2018 Phase 2 trial • 150 Patients • NCT02432703
20%
Headache
8%
Fatigue
7%
Upper Respiratory Tract Infection
7%
Diarrhoea
5%
Nasopharyngitis
1%
Insomnia
1%
Anaphylactic Reaction
1%
Alcohol Use Disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
JNJ-42165279 25 mg

Envision Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-42165279Experimental Treatment1 Intervention
Participants will self-administer 25 milligram (mg) JNJ-42165279 tablets orally twice daily for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will self-administer matching placebo tablets orally twice daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-42165279
2014
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,230 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
220 Patients Enrolled for Autism Spectrum Disorder
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,827 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
220 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Other
Pennsylvania
New York
Texas
How old are they?
18 - 65
What site did they apply to?
Nathan Kline Institute
BioBehavioral Research of Austin, PC
New York Presbyterian Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
2018. "A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03664232.
~12 spots leftby Apr 2025
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