PWS Outcomes Assessment Study | NCT04102839

Studies
PWS Outcomes Assessment Study

NCT04102839

Sponsor

Soleno Therapeutics, Inc.

Status

Completed

Last Update Posted

Nov 4, 2024Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Prader-Willi Syndrome

Interventions

Interview

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2019Actual

Primary Completion Date

Jun 8, 2021Actual

Completion Date

Jun 8, 2021Actual

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Sep 23, 2019

First Posted Date

Sep 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2024

Last Update Posted Date

Nov 4, 2024Actual

Name	Class
Casimir Trials	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Qualitative Interview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Caregivers of PWS patients who are participating in Soleno C601 and C602 Clinical Studies.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Casimir Trials		Plymouth	Massachusetts	02360	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011218	Prader-Willi Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided