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

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).

Timeline

Start

2018-11-07

Primary completion

2022-10-17

Completion

2022-10-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo BID vs JNJ-42165279 25 mg BID; p =0.284 NCT03664232 ↗

registry analysis (superiority test); Placebo BID vs JNJ-42165279 25 mg BID; p =0.290 NCT03664232 ↗

registry analysis (superiority test); Placebo BID vs JNJ-42165279 25 mg BID; p =0.231 NCT03664232 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-42165279	Small molecule	25 mg	Oral

Indications