JNJ-42165279 for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+3 More
JNJ-42165279 - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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 Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism Spectrum Disorder

Study Objectives

3 Primary · 15 Secondary · Reporting Duration: Day 85

Day 85
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 ABI Challenging Behavior Domain Score
Change from Baseline in the ABI Mood and Anxiety Domain Score to Day 85
Change from Baseline in the ABI Self-Regulation Domain Score
Change from Baseline in the Aberrant Behavior Checklist (ABC) Subscales
Change from Baseline in the Autism Behavior Inventory (ABI) Core Domain Score to Day 85
Change from Baseline in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains
Change from Baseline in the Autism Behavior Inventory-Short Form (ABI-S) Scale Domains
Change from Baseline in the Caregiver Global Impression of Severity (Caregiver GI-S)
Change from Baseline in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score
Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Scale Score
Change from Baseline in the Repetitive Behavior Scale - Revised (RBS-R) Scale Score
Change from Baseline in the Social Responsiveness Scale 2 (SRS-2) Score
Change from Baseline in the Zarit Burden Interview (ZBI) Scale Score
Day 85
Caregiver Assessment of Treatment Score
Clinical Global Impression-Improvement (CGI-I)
Self Global Impression of Improvement (Self GI-I) Score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Autism Spectrum Disorder

Side Effects for

JNJ-42165279 25 mg
20%Headache
8%Fatigue
7%Diarrhoea
7%Upper Respiratory Tract Infection
5%Nasopharyngitis
1%Alcohol Use Disorder
1%Anaphylactic Reaction
1%Insomnia
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02432703) in the JNJ-42165279 25 mg ARM group. Side effects include: Headache with 20%, Fatigue with 8%, Diarrhoea with 7%, Upper Respiratory Tract Infection with 7%, Nasopharyngitis with 5%.

Trial Design

2 Treatment Groups

JNJ-42165279
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

78 Total Participants · 2 Treatment Groups

Primary Treatment: JNJ-42165279 · Has Placebo Group · Phase 2

JNJ-42165279
Drug
Experimental Group · 1 Intervention: JNJ-42165279 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-42165279
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 85

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,327,088 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
707 Previous Clinical Trials
3,900,066 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
220 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You need a composite score of 60 or higher on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2) to be eligible for this scholarship.
A person must live with a parent or primary caregiver, or spend the weekend with a parent or primary caregiver, if they are not living with a parent or primary caregiver during each week.
Otherwise healthy and without any chronic conditions, or medically stable with chronic conditions that are well-controlled with medication and without any significant changes in vital signs, 12-lead ECG, or clinical laboratory tests.
I was diagnosed with autism spectrum disorder according to the DSM-5 criteria and my diagnosis was made or confirmed using the ADOS-2
If an individual wants to participate in a pharmacologic, diet, or behavioral intervention study for ASD, they must have started the program at least one month before the beginning of the study and must continue the same program for the entire duration of the study, or have stopped the program at least one month before the beginning of the study.
Can swallow medication whole and self-administer medication if living independently or have a parent or caregiver be able to administer medication.
Subjects must agree to use contraception throughout the study and for 3 months following the final dose.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania33.3%
New York33.3%
Texas16.7%
Other16.7%
How old are they?
18 - 65100.0%
What site did they apply to?
Nathan Kline Institute25.0%
BioBehavioral Research of Austin, PC25.0%
New York Presbyterian Hospital50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%