Clinical trial
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult patients with autism spectrum disorders. In stage I of the study, patients will be randomized to receive daily oral doses of 1.5 mg RG7314or placebo for 12 weeks. After an independent safety review, the study may proceed to stage II. In stage II of the study, additional patients will be randomized to receive daily oral doses of 1.5mg, 4 mg of RG7314 or placebo for 12 weeks. After an interim efficacy and safety analysis, additional patients may be randomized to receive daily oral doses of 1.5 mg, 4 mg of RG7314 or placebo for 12 weeks. The anticipated time on study treatment is 12 weeks.
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Study start date | 2013-02-14 |