PWS Outcomes Assessment Study

Prader-Willi Syndrome Clinical Trial

Official title:

PWS Outcome Assessment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102839
• Other study ID #: CAS-SOL001-01
• Status: Recruiting
• Start date: July 15, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2019
• Source: Soleno Therapeutics, Inc.
• Contact: Megan Hefner, MS
• Phone: 1-774-343-9141
• Email: meganh[@]casimirtrials.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome

Intervention

Other:
• Interview
Qualitative Interview

Locations

Country	Name	City	State
United States	Casimir Trials	Plymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Soleno Therapeutics, Inc.	Casimir Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meaningful Change in Symptom Categories	The percentage of caregivers reporting meaningful change in each of the symptom categories in the Study C601 treated arm versus the Study C601 placebo arm as measured by the five-point quantification scale anchored in the qualitative questions (Scale: 1=very meaningful negative change, 2=slightly meaningful negative change, 3=no meaningful change, 4=slightly meaningful change, 5=very meaningful positive change)	From baseline for interview #2 (Week 13-16), From baseline for interview #3 (Week 26-28), From baseline for interview #4 (Week 65-67)