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PWS Outcomes Assessment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102839
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Casimir Trials
Information provided by (Responsible Party):
Soleno Therapeutics, Inc.

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.


Condition or disease Intervention/treatment
Prader-Willi Syndrome Other: Interview

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Family-Based
Time Perspective: Other
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Interview
    Qualitative Interview


Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Caregivers of PWS patients who are participating in Soleno C601 and C602 Clinical Studies.
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:

  • n/a

Information from the National Library of Medicine

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


Contacts
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Contact: Megan Hefner, MS 1-774-343-9141 meganh@casimirtrials.com

Locations
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United States, Massachusetts
Casimir Trials Recruiting
Plymouth, Massachusetts, United States, 02360
Contact: Marielle Contesse, PhD    425-241-8798    mariellec@casimirtrials.com   
Sponsors and Collaborators
Soleno Therapeutics, Inc.
Casimir Trials

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Responsible Party: Soleno Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04102839    
Other Study ID Numbers: CAS-SOL001-01
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Soleno Therapeutics, Inc.:
Prader-Willi Syndrome
PWS
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders