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NCT05701774 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Prader-Willi Syndrome, sponsored by Soleno Therapeutics.

Active
Registry status
Phase 3
Development phase
83
Enrollment target
20
Study locations

NCT05701774 is a Phase 3 study of Prader-Willi Syndrome that is active but no longer recruiting, run by Soleno Therapeutics. The registered enrollment target is 83 participants, above the 66-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT05701774, a Phase 3 study of Prader-Willi Syndrome, is active but no longer recruiting, sponsored by Soleno Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
83 participants
Enrollment target
20
Study locations

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

4 total trials

What the Registry Record Tells You About NCT05701774

The ClinicalTrials.gov registry entry for NCT05701774 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 66-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (26% higher). The listed sponsor is Soleno Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT05701774 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Other, Florida.

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.

What interventions are being tested in trial NCT05701774?

The interventions under investigation include: DCCR (DRUG).

Who is sponsoring clinical trial NCT05701774?

This trial is sponsored by Soleno Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.