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A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85
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 moreSide effects data
From 2018 Phase 2 trial ā¢ 150 Patients ā¢ NCT0243270320%
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
1,007 Previous Clinical Trials
6,402,292 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
772 Previous Clinical Trials
3,980,319 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
220 Patients Enrolled for Autism Spectrum Disorder