aV1ation

Can we help children
and adolescents with
autism make sense
of the world?

Understanding ASD and
the need for this study
Can I take
part?

About clinical studies

Every year, thousands of adults and children take part in clinical studies (also known as ‘clinical trials’). These are scientific studies that help us make medicine better. Studies like this one compare different dosing plans to help us answer specific questions about potential new treatments.

Each study must be reviewed and approved by regulatory boards before it can begin. It is the job of these boards to protect the safety and rights of a study’s participants.

For more information about your son or daughter’s rights as a research participant, please call Quorum Review at 888-776-9115 (toll free) or visit www.quorumreview.com

About the aViation study

In brief

People with autism spectrum disorder (ASD) often suffer from secondary conditions too (such as sleeping problems, anxiety and attention issues). Although there are medications available to help manage such secondary conditions, we’ve yet to find any that address the social and communication skill issues at the heart of autism. That’s why we’re looking for 300 children and adolescents (aged 5 to 17) with ‘high-functioning’ ASD to join the aViation study. The aViation study will test an investigational medicine that blocks a hormone receptor in the brain linked to the control of socialization, stress, anxiety and aggression. Please note: this study is being conducted only in the United States.

Length

Up to 39 weeks in total

Screening period

(3-8 weeks)
We'll check that your son or daughter is a good fit for this study.

Dosing phase

(24 weeks)
We'll assign your son or daughter a study drug (either the investigational study drug or a placebo). They will take this for up to 24 weeks and we'll collect information about its effects.

Follow-up period

(up to 7 weeks)
We'll give your son or daughter two final health checks.

Dosing

Study drugs will be assigned at random (purely by chance, like the tossing of a coin). Two out of three participants will take daily doses of the investigational study drug and the rest will take daily doses of a placebo. The placebo looks like the investigational study drug but doesn’t contain any medicine.

Both the investigational study drug and the placebo are small tablets that can be swallowed whole or dissolved in liquid. You won’t be told what your son or daughter’s tablets contain and neither will your doctor’s team (except in an emergency).

Monitoring

During the study, your son or daughter will visit a study clinic with you around once every 6 weeks (about 7 times in total). This will allow the study team to assess their:

  • General health
  • Daily living
    skills
  • Communications
    skills
  • Overall ASD
    symptoms
  • Social skills

In between these clinic visits, a nurse will need to take some additional blood samples. To do this, they’ll either visit you at your home or you’ll be asked to go back to the clinic.

The data gathered during both clinic and home visits will help us decide the future of the investigational study drug; the same parent or guardian must be present each time and willing to answer questions about their son or daughter’s condition and health.

Find my local clinic

Thank you for your interest in the aViation study. Please use the map below to search for study clinic near you.