PWS Outcomes Assessment Study

Soleno Therapeutics

Status: Completed

Conditions: Prader-Willi Syndrome

Treatments: Other: Interview

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04102839

CAS-SOL001-01

Details and patient eligibility

About

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 data of PWS patients doing specific activities of daily life.

The purpose of this study is to understand the real-world and nuanced impact of a potential therapeutic on individual PWS patients. The results of this study will complement the outcomes being captured during the Soleno C601/C602 clinical studies.

There is no treatment or intervention associated with this study.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

• n/a