Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCCR 75 - 525 mg DCCR |
Drug: DCCR
Once daily oral administration
|
Outcome Measures
Primary Outcome Measures
- Safety of DCCR (adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. ( Adverse events) [Baseline to Week 262 or until resolution of certain adverse events]
Assess the safety of DCCR by evaluating the incidence and severity of adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
-
Participant must:
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Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
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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
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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:
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Positive urine pregnancy test (in females of child-bearing potential)
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Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
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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.
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.- C614