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NCT04102839 · ClinicalTrials.gov registry record
PWS Outcomes Assessment Study
A clinical trial, sponsored by Soleno Therapeutics.
- Completed
- Registry status
- 59
- Enrollment target
NCT04102839: Completed study, sponsored by Soleno Therapeutics.
NCT04102839 is a clinical trial that has completed, run by Soleno Therapeutics. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04102839 has completed, sponsored by Soleno Therapeutics.
- COMPLETED
- Registry status
- 59 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- OTHER Interview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2021-06-08 |
What the finished NCT04102839 record still lists
NCT04102839 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Interview is the first listed.
NCT04102839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04102839 about?
NCT04102839 is a clinical study titled "PWS Outcomes Assessment Study". 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 understa...
What is the current status of trial NCT04102839?
This trial is currently completed. The enrollment target is 59 participants. The study started on 2019-07-15. Estimated completion is 2021-06-08.
What interventions are being tested in trial NCT04102839?
The interventions under investigation include: Interview (OTHER).
Who is sponsoring clinical trial NCT04102839?
This trial is sponsored by Soleno Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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