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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT04086810
• Date of registration: 10/09/2019
• Prospective Registration: Yes
• Primary sponsor: Soleno Therapeutics, Inc.
• Public title: An Open-Label Study of DCCR Tablet in Patients With PWS
• Scientific title: An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
• Date of first enrolment: October 2019
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT04086810
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Key inclusion & exclusion 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



Age minimum: 4 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Drug: DCCR

Primary Outcome(s)

Adverse Events (Safety) [Time Frame: Baseline to Week 106]

Secondary ID(s)

C603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors