ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

To be considered for this study, you must have already finished the previous ML-004-002 study within the last 90 days. You need to be between 12 and 46 years old when the study starts, and have a clear diagnosis of autism spectrum disorder. It's important that you have someone who can reliably report on your symptoms, such as a family member or carer.

You also need to be able to swallow the study tablets. Your body mass index (BMI) should be 18 or above. If you are taking any other medications for your mental health or any other treatments, they need to have been stable for at least four weeks before you join the study.

There are some reasons why you might not be able to join. These include having certain conditions like Rett syndrome or childhood disintegrative disorder, or if you've had seizures that aren't well controlled, especially in the last six months. The study also cannot include individuals who are at a significant risk of suicidal behaviour, have uncontrolled high blood pressure, or if you are pregnant or breastfeeding. These checks are in place to make sure the study is as safe as possible for everyone involved.

If you decide to take part in this study, you will be given the study medication, ML-004, in tablet form. Both you and the study team will know you are receiving the medication. You'll have regular visits to the study clinic where the research team will check on your health and any effects of the medication. This will involve physical examinations, blood tests, and discussions about how you're feeling and any symptoms you might have. Your care partner will also play a role in reporting on your symptoms. The exact number of visits, tests, and the total duration of your participation will be explained in detail by the study team, but it's an extension of a previous study, so it will involve ongoing assessments.