Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Prader-Willi Syndrome, sponsored by Foundation for Prader-Willi Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Frequency, severity, and seriousness of adverse events during the study.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 3 |
What NCT06144645 shows while recruiting
NCT06144645 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (57% higher).
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 lists 18 locations in 13 states (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.
Learn More About Clinical Trials
Similar trials for Prader-Willi Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06144645's enrollment target sits among peer trials
102 4th of 16 higher than 13 of 16 other Prader-Willi Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prader-Willi Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Pitolisant in Patients With Prader-Willi Syndrome
RECRUITING · Phase 3
-
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
ACTIVE NOT RECRUITING · Phase 3
-
Growth Hormone Use in Adults With Prader-Willi Syndrome
COMPLETED · Phase 3
-
Physical Activity and Community EmPOWERment Project
RECRUITING · NA
-
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
RECRUITING · Phase 1
-
Cerebellar TMS and Satiety in Prader-Willi Syndrome
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704662 · 102 participants · NA
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- NCT04174742 · 102 participants
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
- NCT04275362 · 102 participants
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- NCT04541082 · 102 participants · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI