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

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soleno Therapeutics, Inc.

Criteria

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