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 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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Casimir Trials

Plymouth, Massachusetts, 02360, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Qualitative Interview

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Soleno Therapeutics, Inc.

Industry

Collaborators

Casimir Trials

Registry information

Official study title

PWS Outcome Assessment Study

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 25, 2019
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed