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.