Clinical Trial TitleStudy to Investigate the Efficacy, Safety and Tolerability of RO7017773 in Participants Aged 15 to 45 Years with Autism Spectrum Disorder
National Clinical Trial Number:NCT04299464
Clinical Trial Protocol Description:
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 to 45 Years with Autism Spectrum Disorder
The AuRoRa Borealis Study is evaluating the safety and efficacy of an investigational drug for adolescents and adults (ages 15 to 45) with moderate to severe autism. The investigational drug may help with some of the core symptoms of autism — specifically with social and communication difficulties and restricted and repetitive behaviors. The investigational drug is thought to increase the activity of a neurotransmitter (natural chemical) in the brain called GABA. Researchers believe that the investigational drug may interact with GABA in such a way that it may be helpful in addressing some of the core symptoms of autism.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have been diagnosed with autism
- Be between the ages of 15-45
- Exhibit moderate to severe socialization and communication difficulties
- Exhibit restricted, repetitive behaviors
- Have a study partner or support person who can attend your study visits with you
- Not be pregnant
This is a partial list of inclusion and exclusion criteria.