NCT04299464

A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Autism Spectrum Disorder (ASD)

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive oral placebo for approximately 12 weeks.
DRUG	RO7017773	Participants will receive oral RO7017773 for approximately 12 weeks.

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2020-03-06
• Last updated: 2025-01-28
• Results posted: 2025-01-28

Locations

21 sites across 4 countries: United States, Canada, Italy, Spain

Regulatory

• FDA-regulated drug study