A Multi-center, Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)
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 (ASD). In stage I of the study, patients will be randomized to receive daily oral doses of 1.5 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 patients will be randomized to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks. The anticipated time on study treatment is 12 weeks.
Stanford is now accepting new patients for this trial. Please contact SPECTRUM at for more information.
- drug : Placebo
- drug : RG7314
Phase: Phase 2
Ages Eligible For Study:
- Male adult patients, 18 to 45 years of age - Patients meet DSM-5 criteria for ASD and ICD10 criteria for Autism diagnosis - Social Responsiveness Scale > / = 66 - Clinical Global Impressions Severity (CGI-S) > = 4 (moderately ill) - Patients have an IQ > = 70 - A body mass index (BMI) between 18 to 40 kg/m2 inclusive - Language, hearing and vision compatible with the study measurements as judged by the investigator - Lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the patient's compliance with protocol-specified procedures and study medication dosing, and report on the patient's status via completion of study assessments. Any period of absence must be covered by another caregiver. Non-cohabitating caregiver(s) must spend sufficient time with the subject so that, in the opinion of the investigator, the caregiver(s) can reliably assess patient's mental status, activities and behavior.
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305