Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

To join this study, a person must have already taken part in a previous DCCR study, specifically 'Study C602'. This includes people who completed the main part of that study, or those who left early but a certain amount of time has passed since then. It also includes people who were in the extended part of Study C602 but chose not to join the next stage, as long as enough time has gone by.

There are also some reasons why someone could not join. For example, if you are a female and are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or shortly after, you would not be able to take part. Also, if you are currently participating in another study that involves a new drug or treatment, you would not be eligible for this study. All participants or their parents/guardians will need to give their informed consent, meaning they understand and agree to take part.

If you join this study, it would involve continuing to take the DCCR medicine as prescribed. The study team will regularly check your health to monitor the long-term safety of the medicine. This will include visits to the clinic where doctors and nurses will carry out various checks and assessments, though the detailed schedule isn't provided here. You'll be taking the DCCR tablets, and the team will keep a close eye on any effects, both positive and negative. The total duration of your participation isn't specified in detail but is focused on long-term safety, meaning it could last for an extended period.