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

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

Study Overview

• Status: Withdrawn
• Conditions: Prader-Willi Syndrome
• Intervention / Treatment: Drug: DCCR

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCCR; 25 - 450 mg DCCR	Drug: DCCR; Once daily oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (Safety)	Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.	Baseline to Week 106

Collaborators and Investigators

• Sponsor: Soleno Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Prader-Willi Syndrome; PWS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Syndrome; Prader-Willi Syndrome
• Other Study ID Numbers: C603

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No