An Exploratory, Multicenter, Randomized, double-blind, placebo-controlled study evaluating the effect and safety of pitolisant in children and adolescents with Autism Spectrum Disorders.

This research study is looking into a new use for a medicine called pitolisant, which is also known by the brand name Wakix. It's being tested in children and teenagers who have autism spectrum disorders. The main aim is to see if this medicine can help improve social skills and communication, which are areas many people with autism find challenging. Researchers will also be very carefully watching to make sure the medicine is safe and to track any side effects.

This is a 'Phase II' study, which means it's an early step in testing a new medicine. It's designed to explore whether the medicine works and find the right dose, rather than confirm its effectiveness. Participants will either receive the actual medicine or a 'dummy' pill (called a placebo) that looks the same but contains no active medicine. This helps researchers compare the two groups and figure out if any changes are truly caused by the study medicine.

To measure how well the medicine works, researchers will use special questionnaires and assessments that look at social skills, daily living abilities, and sleep patterns. They will also keep a close eye on behaviour and any changes in health.