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NCT04086810 Clinical Trial

An Open-Label Study of DCCR Tablet in Patients With PWS

Prader-Willi Syndrome Clinical Trial

Official title:
An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04086810
Other study ID # C603
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date October 2019
Est. completion date October 2019

Study information
Verified date September 2019
Source Soleno Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DCCR
Once daily oral administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Soleno Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events (Safety) Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported. Baseline to Week 106
See also
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