Status:
WITHDRAWN
An Open-Label Study of DCCR Tablet in Patients With PWS
Lead Sponsor:
Soleno Therapeutics, Inc.
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04086810
Start Date
October 1 2019
End Date
October 1 2019
Last Update
August 3 2021
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