Study Stopped
Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.
An Open-Label Study of DCCR Tablet in Patients With PWS
An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedAugust 3, 2021
September 1, 2019
Same day
September 10, 2019
July 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events (Safety)
Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
Baseline to Week 106
Study Arms (1)
DCCR
EXPERIMENTAL25 - 450 mg DCCR
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2019
First Posted
September 12, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
August 3, 2021
Record last verified: 2019-09