A Phase II Multicenter, Randomized, Double-Blind, 12-Week Treatment, 3-Arm, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 104
- Locations
- 21
- Primary Endpoint
- Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Study Overview
Brief Summary
This study will investigate the efficacy, safety, tolerability, and pharmacokinetics of RO7017773 in participants aged 15-45 years who have been diagnosed with ASD with a score of >/=50 on the Wechsler Abreviated Scale of Intelligence (WASI-II).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants will receive placebo matched to RO7017773 for approximately 12 weeks.
Intervention: Placebo (Drug)
RO7017773 Low Dose
Participants will receive a fixed low dose of RO7017773 for approximately 12 weeks.
Intervention: RO7017773 (Drug)
RO7017773 High Dose
Participants will receive a fixed high dose of RO7017773 for approximately 12 weeks.
Intervention: RO7017773 (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Week 12 in the Adaptive Behavior Composite (ABC) Score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time Frame: Baseline to Week 12
Vineland-3 is a semi-structured interview that measures an individual's adaptive behavior across 3 domains: Communication, Socialization, and Daily Living skills. Each domain is composed of 3 subdomains. Subdomain raw score is based on item responses (3-point scale: 0=never present; 1=sometimes present; 2=usually present) and is calculated for each subdomain of the three main domains as the sum of the scores for each item within the subdomain. Raw scores of the 9 subdomains are used to derive Growth Scale Values (GSVs; range = 10-197). A conversion table for mapping raw scores to GSV scores is found in Appendix 3, Table B.2 in the Vineland-3 manual (Sparrow et al. 2016). GSV is a person-ability score used to track an individual's progress. Vineland-3 ABC Composite GSV score is calculated as the mean GSV score (summing the 9 GSV subdomain scores and dividing by 9; Vineland-3 ABC Composite GSV scores can range from 10-154). A higher score indicates better adaptive functioning.
Secondary Outcomes
- Number of Participants With at Least One Adverse Events (AEs)(Up to Week 18)
- Number of Participants With at Least One Serious Adverse Events (SAEs)(Up to Week 18)
- Number of Participants Discontinuing Treatment Due to AEs(Day 1 up to Week 12)
- Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behaviour as Measured Using the Columbia-Suicide-Severity Rating Scale (C-SSRS)(Baseline up to Week 18)
- Change From Baseline in Karolinska Sleepiness Scale (KSS) Score for Assessing Daytime Sleepiness(Baseline (Day 1 Predose), 3-4 hours post-dose on Day 1, Predose and 3-4 hours post-dose on Days 14, 42, and 84)
- Change From Baseline in Epworth Sleepiness Scale Score (ESS) for Assessing Daytime Sleepiness(Baseline (Day 1), Days 14, 42, and 84)
- Change From Baseline ESS Score for Children and Adolescents (ESS-CHAD) for Assessing Daytime Sleepiness(Baseline (Day 1), Days 14, 42, 63, and 84)
- Number of Participants With Daytime Sleepiness Assessed Using Sudden Onset of Sleep Questionnaire(Baseline (Day 1), Days 7, 14, 42, 63, and 84)
- Change From Baseline to Week 12 in Behavior/Symptoms as Measured by All Domains of the Repetitive Behavior Scale-Revised (RBS-R) Score(Baseline to Week 12)
- Change From Baseline to Week 12 on the Vineland-3 Socialization Domain(Baseline to Week 12)
- Change From Baseline to Week 12 on the Vineland-3 Communication Domain(Baseline to Week 12)