Current Research Studies
Autism - V1ADUCT: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Balovaptan in Adults with Autism Spectrum Disorder with a 2-Year Open Label Extension
What is the goal of this study?
The goal of this study is to look at the effect of valovaptan, an investigational drug, to see if it can help adults with autism spectrum disorder (ASD) manage certain social and communication challenges a little easier.
Balovaptan works by blocking a brain receptor of a hormone that is believed to be associated with control of socialization, stress, anxiety, affection and aggression. Balovaptan could therefore be a potential treatment for some of the core symptoms associated with autism.
Who can join the study?
This study may be a good fit for young adults who
- Are at least 18 years old
- Have been diagnosed with autism spectrum disorder (ASD)
- Have someone they see and speak to regulary, who is willing to be their "study partner" for the duration of the trial
- Are medically stable
What will happen if my child takes part in this study?
The study has 4 parts:
- Screening (to determine eligibility; up to 1 month in length)
- Main treatment period (approximately 6 months in length)
- Open-label extension period (up to 2 years in length), optional participation
- Follow-up period (approximately 3 months in length)
The total time participants will be in the study will be about 3 years (if participating in the main and the open-label extension periods).
If eligible, participants will be randomly assigned to one of the following treatment groups: balovaptan or placebo.
For the open-label extension (optional) all participants would receive balovaptan.
Participants will be required to take the medication daily, have regular health checks (approximately once a month) to monitor safety and well-being at Seattle Children's and complete some questionnaires.
There is no cost for the study procedures. Some compensation is provided for attending the clinic visits.
Who can I contact for more information?
To learn more, call 206-987-7502 or email the study coordinator.