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NCT06144645 · ClinicalTrials.gov registry record · Phase 3

A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS

A Phase 3 study of Prader-Willi Syndrome, sponsored by Foundation for Prader-Willi Research.

Recruiting
Registry status
Phase 3
Development phase
102
Enrollment target
18
Study locations

NCT06144645 is a Phase 3 study of Prader-Willi Syndrome that is actively recruiting participants, run by Foundation for Prader-Willi Research. The registered enrollment target is 102 participants, above the 65-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (57% higher). The trial reports 18 study locations across 13 states.

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The verdict

NCT06144645, a Phase 3 study of Prader-Willi Syndrome, is actively recruiting participants, sponsored by Foundation for Prader-Willi Research.

RECRUITING
Registry status
Phase 3
Development phase
102 participants
Enrollment target
18
Study locations

Study Summary

The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.

Conditions Studied

Prader-Willi Syndrome

Interventions

  • DEVICE tVNS, intermittent stimulation
  • DEVICE tVNS, continuous stimulation

Study Locations (18)

New York

  • Maimonides Medical Center - Brooklyn
  • NYU Langone Health - Garden City
  • Montefiore Medical Center and Albert Einstein College of Medicine - The Bronx

California

  • Stanford University - Palo Alto
  • Rady Children's Hospital San Diego - San Diego

Georgia

  • Emory University - Atlanta
  • Rare Disease Research - Atlanta

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland
  • Nationwide Children's Hospital - Columbus

Colorado

  • Children's Hospital Colorado - Aurora

Iowa

  • University of Iowa - Iowa City

Maryland

  • Johns Hopkins Hospital - Baltimore

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2024-01-08
Est. Completion 2027-12-01
Phase Phase 3

Sponsor

Foundation for Prader-Willi Research

3 total trials

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What the Registry Record Tells You About NCT06144645

The ClinicalTrials.gov registry entry for NCT06144645 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 65-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (57% higher). The listed sponsor is Foundation for Prader-Willi Research, which has 3 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 2 interventions - of which tVNS, intermittent stimulation is the first listed.

NCT06144645 reports 18 study locations spanning 13 distinct geographic areas - top geographies include New York, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT06144645 about?

NCT06144645 is a clinical study titled "A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS". The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.

What is the current status of trial NCT06144645?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2024-01-08. Estimated completion is 2027-12-01.

What conditions does trial NCT06144645 study?

This clinical trial studies the following conditions: Prader-Willi Syndrome.

What interventions are being tested in trial NCT06144645?

The interventions under investigation include: tVNS, intermittent stimulation (DEVICE), tVNS, continuous stimulation (DEVICE).

Who is sponsoring clinical trial NCT06144645?

This trial is sponsored by Foundation for Prader-Willi Research, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06144645 being conducted?

This trial has 18 study locations across California, Colorado, Georgia, Iowa, 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.