Status:
COMPLETED
PWS Outcomes Assessment Study
Lead Sponsor:
Soleno Therapeutics, Inc.
Collaborating Sponsors:
Casimir Trials
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This is a longitudinal study during which qualitative interviews will be conducted with caregivers of Soleno C601/C602 study subjects. There is an additional option for caregivers to collect video dat...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for Interviews:
- Eligible caregivers must:
- Be willing and able to provide informed consent in English
- Care for a C601/C602 trial subject or potential trial subject
- Have access to a smartphone or the internet
- Be able to converse in English
- Key Inclusion Criteria for Video Capture:
- Eligible PWS participants for the optional daily life video capture must:
- Be willing and able to provide informed consent or assent.
- Be enrolled in the C601/C602 trial
- Be able to converse in English
- Have a caregiver who has access to an Apple or Android smartphone or has internet access and is willing to use a wi-fi-only device to record and upload videos
- Have a caregiver who is willing and able to record activity videos
Exclusion
- n/a
Key Trial Info
Start Date :
July 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04102839
Start Date
July 15 2019
End Date
June 8 2021
Last Update
November 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Casimir Trials
Plymouth, Massachusetts, United States, 02360