Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

Soleno Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Prader-Willi Syndrome

Treatments: Drug: DCCR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05701774

C614

Details and patient eligibility

About

The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.

Enrollment: 83 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)

2. Participant must:

   1. Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
   2. Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or
   3. Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit.

Exclusion criteria

1. Positive urine pregnancy test (in females of child-bearing potential)
2. Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
3. Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

DCCR

Experimental group

Description:

75 - 525 mg DCCR

Treatment:

Drug: DCCR