Summary:
If you know a child between 6 and 17 years of age who experiences irritability related to autism, they may be able to join the Illuminate-325 clinical research study.
Autistic disorder (autism) is a developmental disorder that begins in childhood. Autism may affect a child’s social interactions, communication, interests, behaviors, and mannerisms (the core symptoms of autism). Every child with autism will be affected in different ways and it is common to experience irritability, depression, and anxiety alongside the core symptoms.
What are the treatment options for autism?
There are currently no medicines approved for treating the core symptoms of autism. However,
a range of therapies have been recommended by the American Academy of Pediatrics that may
help children with autism live a more fulfilling life:
- Behavioral therapy including social skills training may improve behavior and communication.
- Speech therapy may help a child with autism improve language and social skills.
- Occupational or physical therapy may help improve coordination and life skills.
- Sensory integration therapy may help children to understand and better cope with sensory
information (e.g. touch, sound, taste, and smell).
- Medicines are sometimes used to treat specific problems associated with autism, including
irritability, depression, anxiety, hyperactivity, and obsessive-compulsive behaviors.
What is the Illuminate-325 Study?
The Illuminate-325 Study is looking at an investigational medication called lurasidone
to find out whether it is safe and effective in managing irritability in children and teenagers
with autism. Lurasidone is a type of medicine that has already been approved in adults
with schizophrenia and depressive episodes associated with bipolar I disorder
(bipolar depression). The goal of this study is to learn more about managing
autism-related irritability and potentially to increase future treatment options
for children with autism.
If a child is eligible to participate in this study, all study-related health assessments
and study medication will be provided at no cost.
Who can participate in the Illuminate-325 Study?
We are looking for about 150 patients to join this study. A child may be eligible to participate
in the study if they:
- are 6–17 years of age
- have been diagnosed with autism (autistic disorder)
- have irritability symptoms of autism such as aggression, tantrums, or rapidly changing moods
- would be willing and able to swallow two tablets per day during the treatment phase of the
study (6 weeks).
What will study participation involve?
Young children and teenagers joining the study will need to attend approximately 10 study center visits for a period of up to 10 weeks. A reliable adult (parent, legal guardian, or caregiver) will need to accompany the child to every visit and may need to answer questions on their behalf.
At these visits, the study doctor will assess the child’s autistic symptoms and ask questions about how the symptoms are affecting their life. The child’s overall health will be monitored throughout the study using:
- physical examinations
- blood pressure and heart rate tests
- blood tests
- urine tests
Children participating in the study will be asked to fast (not eat or drink anything except water)
for 8 hours prior to certain study procedures.