A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of
concept study will investigate the efficacy and safety of RG7314 in adult participants with
ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral
doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety
review, the study may proceed to Stage II. In Stage II of the study, additional participants
will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks.
After an independent safety review, Stage III will be started wherein additional participants
will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12
weeks. During Stage III, safety will be reviewed by independent safety review twice and if no
safety signal is observed, then additional participants will be randomized in 1:1:1 either to
receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in
Stage IV.