A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
NCT ID: NCT03664232
Last Updated: 2025-04-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2018-11-07
2022-10-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TB006 for Autism Spectrum Disorder
NCT06500637
A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder
NCT05067582
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
NCT06757504
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
NCT05081245
Double Blind Trial in Children With Autism Spectrum Disorder
NCT06058962
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
JNJ-42165279
Participants will self-administer 25 milligram (mg) JNJ-42165279 tablets orally twice daily for 12 weeks.
JNJ-42165279
Participants will receive 25 mg JNJ-42165279 orally twice daily for 12 weeks.
Placebo
Participants will self-administer matching placebo tablets orally twice daily for 12 weeks.
Placebo
Participants will receive a matching placebo orally twice daily for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JNJ-42165279
Participants will receive 25 mg JNJ-42165279 orally twice daily for 12 weeks.
Placebo
Participants will receive a matching placebo orally twice daily for 12 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
13 Years
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
42165279AUT2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108275
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.