PWS Outcomes Assessment Study
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|ClinicalTrials.gov Identifier: NCT04102839|
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
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.
|Condition or disease||Intervention/treatment|
|Prader-Willi Syndrome||Other: Interview|
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|Official Title:||PWS Outcome Assessment Study|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
- Other: Interview
- Meaningful Change in Symptom Categories [ Time Frame: From baseline for interview #2 (Week 13-16), From baseline for interview #3 (Week 26-28), From baseline for interview #4 (Week 65-67) ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102839
|Contact: Megan Hefner, MSfirstname.lastname@example.org|
|United States, Massachusetts|
|Plymouth, Massachusetts, United States, 02360|
|Contact: Marielle Contesse, PhD 425-241-8798 email@example.com|