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

• Sponsor: Soleno Therapeutics, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04086810
• Collaborator: (none)
• Enrollment: 0
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prader-Willi Syndrome	Drug: DCCR	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
• Anticipated Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Oct 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse Events (Safety) [Baseline to Week 106]

   Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Soleno Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soleno Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04086810
• Other Study ID Numbers: C603
• First Posted: Sep 12, 2019
• Last Update Posted: Aug 3, 2021
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Soleno Therapeutics, Inc.: PWS; Prader-Willi Syndrome
• Additional relevant MeSH terms: Prader-Willi Syndrome; Syndrome

Study Results

No Results Posted as of Aug 3, 2021