An Open-Label Study of DCCR Tablet in Patients With PWS
Primary Purpose
Prader-Willi Syndrome
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DCCR
Sponsored by
About this trial
This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring PWS, Prader-Willi Syndrome
Eligibility Criteria
Inclusion Criteria:
- Successful completion of clinical study C602, Visit 15
- Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
- Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.
Exclusion Criteria:
- Positive urine pregnancy test (in females of childbearing potential)
- Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
- Any new disease, condition, or circumstance, which may significantly impact subject safety
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCCR
Arm Description
25 - 450 mg DCCR
Outcomes
Primary Outcome Measures
Adverse Events (Safety)
Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
Secondary Outcome Measures
Full Information
NCT ID
NCT04086810
First Posted
September 10, 2019
Last Updated
July 29, 2021
Sponsor
Soleno Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04086810
Brief Title
An Open-Label Study of DCCR Tablet in Patients With PWS
Official Title
An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soleno Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
Keywords
PWS, Prader-Willi Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCCR
Arm Type
Experimental
Arm Description
25 - 450 mg DCCR
Intervention Type
Drug
Intervention Name(s)
DCCR
Intervention Description
Once daily oral administration
Primary Outcome Measure Information:
Title
Adverse Events (Safety)
Description
Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
Time Frame
Baseline to Week 106
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful completion of clinical study C602, Visit 15
Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.
Exclusion Criteria:
Positive urine pregnancy test (in females of childbearing potential)
Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
Any new disease, condition, or circumstance, which may significantly impact subject safety
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study of DCCR Tablet in Patients With PWS
We'll reach out to this number within 24 hrs