DCCR for Prader-Willi Syndrome

Recruiting at 22 trial locations

Overseen By C614 Project Manager

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Soleno Therapeutics, Inc.

Disqualifiers: Pregnancy, Breastfeeding, Recent investigational study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Long-term

83 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with Prader-Willi Syndrome who have previously participated in a specific study (C602) and completed it, or discontinued from it at least 16 weeks prior. They must provide consent to participate.

Inclusion Criteria

Participant must have participated in and completed the Study C602 Randomized Withdrawal (RW) Period

I was in Study C602 but stopped participating at least 16 weeks ago.

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

Exclusion Criteria

Positive urine pregnancy test (in females of child-bearing potential)

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.

I am not pregnant, breastfeeding, nor planning to become pregnant within 30 days after the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DCCR (diazoxide choline) extended-release tablets to evaluate long-term safety

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DCCR

Trial Overview The trial is testing the long-term safety of DCCR tablets for patients with Prader-Willi Syndrome. It's an open-label extension, meaning everyone knows they're getting the actual drug, not a placebo.

Participant Groups

Group I: DCCR Experimental Treatment 1 Intervention

75 - 525 mg DCCR

Who Is Running the Clinical Trial?

Soleno Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

410+