Children and adolescents with ASD show multiple and persistent deficits in social communication and social interactions associated with restricted interests and stereotyped and repetitive behaviours.

Children and adolescents with ASD have difficulty with verbal and non-verbal communication. For example, they may not understand or appropriately use: spoken language, gestures, eye contact or facial expressions.

Additional social challenges can include difficulty with: recognizing emotions and intentions in others, recognizing one’s own emotions, seeking emotional comfort from others or feeling overwhelmed in social situations.

Restricted and repetitive behaviours can include: repetitive body movements (e.g. rocking, flapping, spinning, running back and forth), repetitive motions with objects, ritualistic behaviors, narrow or extreme interests in specific topics or need for unvarying routine/resistance to change (e.g. same daily schedule, meal menu, clothes, route to school).

The cause of ASD is still poorly understood, but it seems highly genetically heritable and possible environmental risks factors have also been identified.

There is currently no approved medication for the main characteristics of autism such as impaired social interactions and restricted behaviours. Medications that are currently available target only related symptoms of autism, such as insomnia, irritability or depressive symptoms.

The aim of the Autism Clinical studies is to evaluate if an investigational medication is efficient and safe to treat the symptoms of Autism Spectrum Disorder in children and adolescents (from 2 to less than 18 years old).