A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
Completed · Phase 2 · Has a placebo group
Conditions studied: Autism Spectrum Disorder
In brief
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).
Key facts
- Study ID
- NCT03664232
- Run by
- Janssen Research & Development, LLC
- People needed
- 78
- Starts
- 2018-11-07
- Expected to finish
- 2022-10-28
- Last updated by the study team
- 2025-04-23
Who can join
Age: 13 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Autism Spectrum Disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) (minimum score of 8 [autism spectrum])
- Otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Have a composite score on Kaufman Brief Intelligence Test, Second Edition (KBIT-2) of at least 60
- Must live with a parent or primary caregiver or, if not, during each week he/she must either (A) spend at least 3 hours a day for at least 4 days or, (B) spend the weekend with a parent or primary caregiver
- Any pharmacologic, diet, or behavioral intervention for ASD must have begun at least 1 month prior to the baseline visit and continue unchanged through the treatment period, or have ended at least 1 month prior to the baseline visit
- Must be able to swallow the study medication whole and self-administer medication if living independently or have a parent or caregiver be able to administer medication
- Must agree to abide by the birth control requirements during the study and for 3 months after the last dose
You may not qualify if…
- Current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
- Use of a drug with moderate/strong cytochrome P450 (CYP)3A4 inhibiting or inducing properties at, or prior to, screening that is not discontinued at least within 1 month prior to Day 1
- History of drug or alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (except if related to current treatment)
- Currently taking or has taken within the past month recreational or medically prescribed cannabis
Where it is running
- Harmonex Neuroscience Research — Dothan, Alabama, United States
- Southwest Autism Research and Resource Center — Phoenix, Arizona, United States
- NRC Research Institute — Orange, California, United States
- New York Presbyterian Hospital — New York, New York, United States
- Nathan Kline Institute — Orangeburg, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Cutting Edge Research Group — Oklahoma City, Oklahoma, United States
- BioBehavioral Research of Austin PC — Austin, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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