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ACTIVE NOT RECRUITING Phase 3

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

NCT05701774 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG DCCR

Study Locations (20)

California

  • UC Irvine — Orange
  • Stanford University — Palo Alto
  • Rady Children's Hospital of San Diego — San Diego

Other

  • Fulbourn Hospital — Cambridge
  • The Queen Elizabeth University — Glasgow
  • Hull and East Yorkshire Hospitals NHS Trust — Hull

Florida

  • U of Florida Gainesville — Gainesville

Georgia

  • Emory Children's Center — Atlanta

Indiana

  • Indiana University School of Medicine — Indianapolis

Maryland

  • National Institutes of Health — Bethesda

Massachusetts

  • Boston Children's Hospital — Boston

Michigan

  • Sparrow Clinical Research Institute — Lansing

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2023-01-31
Est. Completion 2028-06
Phase Phase 3

Sponsor

Soleno Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05701774

The ClinicalTrials.gov registry entry for NCT05701774 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Soleno Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 1 intervention — of which DCCR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05701774 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05701774 about?

NCT05701774 is a clinical study titled "Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome". 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.

What is the current status of trial NCT05701774?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2023-01-31. Estimated completion is 2028-06.

What conditions does trial NCT05701774 study?

This clinical trial studies the following conditions: Prader-Willi Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05701774?

The interventions under investigation include: DCCR (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05701774?

This trial is sponsored by Soleno Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05701774 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial