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

Korábbi kezelés

• Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.

Egyéb

• Positive urine pregnancy test (in females of child-bearing potential)
• Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.

• Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
• Participant must:
  • Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
  • Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or
  • Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit.