NCT03664232

A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Subjects With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 13 Years – 35 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	JNJ-42165279	Participants will receive 25 mg JNJ-42165279 orally twice daily for 12 weeks.
DRUG	Placebo	Participants will receive a matching placebo orally twice daily for 12 weeks.

Timeline

• Start date: 2018-11-07
• Primary completion: 2022-10-17
• Completion: 2022-10-28
• First posted: 2018-09-10
• Last updated: 2025-04-23
• Results posted: 2025-04-23

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study