An Open-Label Study of DCCR Tablet in Patients With PWS

An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome

The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.

Inclusion Criteria:

• Successful completion of clinical study C602, Visit 15
• Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
• Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.

Exclusion Criteria:

• Positive urine pregnancy test (in females of childbearing potential)
• Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
• Any new disease, condition, or circumstance, which may significantly impact subject safety