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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
JNJ-42165279
Participants will self-administer 25 milligram (mg) JNJ-42165279 tablets orally twice daily for 12 weeks.
干预措施: JNJ-42165279 (Drug)
Placebo
Participants will self-administer matching placebo tablets orally twice daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour)
时间窗: Baseline (Day 1) to Day 85
ABI:62-item questionnaire to track outcomes in autism spectrum disorder (ASD). Each item was answered on 1 of 2 possible dimensions: quality (how well person carries out particular behavior; 1 to 13 items) or frequency (how often particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score=severe symptoms/more frequency. ABI core domain score was from 2 domains: social communication (23 items; 3 sub-domains) and repetitive/restrictive behavior (RRB;15 items; 4 sub-domains). Domain and sub-domain scores: calculated as average of non-missing items (ie, sum of all non-missing items divided by number of non-missing items); scores ranged from 0 to 3, higher scores=more severe symptoms of ASD. ABI core domain score=sum of social communication and RRB domain scores divided by total number of items in these 2 domains. Negative changes in ABI core domain score=improvement.
Change From Baseline to Day 85 in the ABI Social Communication Domain Score
时间窗: Baseline (Day 1) to Day 85
ABI was 62-item questionnaire completed on a web/mobile application or on paper. It tracks outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. The ABI social communication domain score consisted of 23 items; with 3 sub-domains. The domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). For both domains and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. Negative change in score indicates improvement.
Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score
时间窗: Baseline (Day 1) to Day 85
ABI is 62-item questionnaire completed on a web/mobile application or on paper. It tracks outcomes in ASD. Each ABI item was answered on 1 of 2 possible dimensions, quality (how well a person carries out a particular behavior; 1 to 13 items) or frequency (how often a particular behavior occurs; 14 to 62 items). Each item was rated on scale of 0 (never) to 3 (very often) for frequency and 0 (without help) to 3 (not at all) for quality. Higher score indicated severe symptoms/more frequency. The ABI RRB domain score consisted of 15 items; with 3 sub-domains. The domain and sub-domain scores were calculated as the average of the non-missing items (ie, sum of all non-missing items divided by the number of non-missing items). For both domains and its sub-domains, scores ranged from 0 to 3 with higher scores indicating more severe symptoms of ASD. Negative change in score indicates improvement.
Change From Baseline to Day 85 in the Social Responsiveness Scale 2 (SRS-2) Total T-Score
时间窗: Baseline (Day 1) to Day 85
SRS-2: 65-item scale measured extent of autistic social impairment and included 5 subscales: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behavior. Each of 65 items had 4 responses: not true, sometimes true, often true, and almost always true. Scoring value for each item was 0 to 3. If a response to an item was missing, then pre-defined median value for item (0 or 1) was imputed. SRS-2 was not scored if 7 or more item responses were missed. Total raw score was sum of item response values. Each subscale was obtained by adding response values and converted total raw score to standardized T-score based on gender and rater (parent or caregiver). Total T-score was categorized: within normal limits (\<=59), mild (60 to 65), moderate (66 to 75) and severe (\>=76). For total score T-score, higher scores=more severe symptoms. SRS T-score had mean of 50 and standard deviation of 10. Negative changes in T-scores=improvement.
次要结局
- Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores(Baseline (Day 1) to Day 71)
- Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the Clinical Global Impression-Severity (CGI-S) Scale Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the Zarit Burden Interview (ZBI) Global Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the Repetitive Behavior Scale - Revised (RBS-R) Subscale Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score(Baseline (Day 1) to Day 85)
- Change From Baseline to Day 85 in the Caregiver Global Impression of Severity (Caregiver GI-S) Scale Score(Baseline (Day 1) to Day 85)
- Caregiver Assessment of Treatment: Question 1: Number of Participants With Overall Status (Improvement) of Autism at Day 85(At Day 85)
- Caregiver Assessment of Treatment: Question 2: Number of Participants With Improvement in Specific Symptoms During Treatment at Day 85(At Day 85)
- Caregiver Assessment of Treatment: Question 3: Number of Participants With Interest in Continuing Treatment at Day 85(At Day 85)
- Self Global Impression of Improvement (Self GI-I) Scale Score at Day 85(At Day 85)
- Clinical Global Impression-Improvement (CGI-I) Score (Frequency Distribution) at Day 85(At Day 85)