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)

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).

Timeline

Start

2021-03-31

Primary completion

2024-05-15

Completion

2024-05-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Alogabat 20 mg; p = 0.7650; Difference in Adjusted Mean -0.432 (80% CI -2.291 to 1.428); ANCOVA NCT04299464 ↗

registry analysis (superiority test); Placebo vs Alogabat 60 mg; p = 0.7517; Difference in Adjusted Mean -0.4444 (80% CI -2.250 to 1.363); ANCOVA NCT04299464 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alogabat	Small molecule	—	Oral

Indications