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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

Summary

This trial is testing a drug called JNJ-42165279 to see if it can help people with Autism Spectrum Disorder (ASD). Researchers will use a tool called the Autism Behavior Inventory (ABI) to measure any improvements in symptoms.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 ā€¢ 150 Patients ā€¢ NCT02432703
20%
Headache
8%
Fatigue
7%
Upper Respiratory Tract Infection
7%
Diarrhoea
5%
Nasopharyngitis
1%
Anaphylactic Reaction
1%
Alcohol Use Disorder
1%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
JNJ-42165279 25 mg
Placebo

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
1,004 Previous Clinical Trials
6,402,729 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
770 Previous Clinical Trials
3,978,469 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
220 Patients Enrolled for Autism Spectrum Disorder
~11 spots leftby Nov 2025
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