Clinical trial NCT03664232: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 78
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour)
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the ABI Social Communication Domain Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Social Responsiveness Scale 2 (SRS-2) Total T-Score
timeFrame: Baseline (Day 1) to Day 85
Secondary outcomes:
measure: Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores
timeFrame: Baseline (Day 1) to Day 71
measure: Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Clinical Global Impression-Severity (CGI-S) Scale Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Repetitive Behavior Scale - Revised (RBS-R) Subscale Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Zarit Burden Interview (ZBI) Global Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score
timeFrame: Baseline (Day 1) to Day 85
measure: Change From Baseline to Day 85 in the Caregiver Global Impression of Severity (Caregiver GI-S) Scale Score
timeFrame: Baseline (Day 1) to Day 85
measure: Caregiver Assessment of Treatment: Question 1: Number of Participants With Overall Status (Improvement) of Autism at Day 85
timeFrame: At Day 85
measure: Caregiver Assessment of Treatment: Question 2: Number of Participants With Improvement in Specific Symptoms During Treatment at Day 85
timeFrame: At Day 85
measure: Caregiver Assessment of Treatment: Question 3: Number of Participants With Interest in Continuing Treatment at Day 85
timeFrame: At Day 85
measure: Self Global Impression of Improvement (Self GI-I) Scale Score at Day 85
timeFrame: At Day 85
measure: Clinical Global Impression-Improvement (CGI-I) Score (Frequency Distribution) at Day 85
timeFrame: At Day 85
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Orangeburg
country: United States
facility: Nathan Kline Institute
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Austin
country: United States
facility: BioBehavioral Research of Austin PC
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: