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’re 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" (for this study, that means an IQ of
at least 70) ASD to join the aViation study. The aViation study will test
an investigational drug 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 drug
and the rest will take daily doses of a placebo. The placebo looks like the investigational drug but doesn’t contain any medicine.
Both the investigational 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.
You will also be asked to measure your son or daughter’s body temperature and record it in a diary that we will give you.
The data gathered during both clinic and home visits will help us decide the future of the
investigational 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.