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NCT04874155 · ClinicalTrials.gov registry record · NA
Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)
A NA study of Restless Legs Syndrome, sponsored by Noctrix Health.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
- 7
- Study locations
NCT04874155 is a NA study of Restless Legs Syndrome that has completed, run by Noctrix Health. The registered enrollment target is 133 participants, above the 87-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (53% higher). The trial reports 7 study locations across 7 states.
The verdict
NCT04874155, a NA study of Restless Legs Syndrome, has completed, sponsored by Noctrix Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
- 7
- Study locations
Study Summary
Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary RLS
Conditions Studied
Interventions
- DEVICE NTX100 Neuromodulation System - Active
- DEVICE NTX100 Neuromodulation System - Sham
- DEVICE NTX100 Neuromodulation System - Open-Label
Study Locations (7)
California
- California Center for Sleep Disorders - San Leandro
Colorado
- Delta Waves, Inc. - Colorado Springs
Georgia
- Neurotrials Research - Atlanta
Missouri
- Clayton Sleep Institute - St Louis
Ohio
- Ohio Sleep Medicine Institute - Dublin
South Carolina
- Bogan Sleep Consultants, LLC - Columbia
Texas
- FutureSearch Trials of Neurology - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2022-04-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04874155
The ClinicalTrials.gov registry entry for NCT04874155 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (53% higher). The listed sponsor is Noctrix Health, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Restless Legs Syndrome appearing as the primary indexed condition, and to 3 interventions - of which NTX100 Neuromodulation System - Active is the first listed.
NCT04874155 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT04874155 about?
NCT04874155 is a clinical study titled "Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)". Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary RLS
What is the current status of trial NCT04874155?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2021-05-06. Estimated completion is 2022-04-08.
What conditions does trial NCT04874155 study?
This clinical trial studies the following conditions: Restless Legs Syndrome.
What interventions are being tested in trial NCT04874155?
The interventions under investigation include: NTX100 Neuromodulation System - Active (DEVICE), NTX100 Neuromodulation System - Sham (DEVICE), NTX100 Neuromodulation System - Open-Label (DEVICE).
Who is sponsoring clinical trial NCT04874155?
This trial is sponsored by Noctrix Health, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04874155 being conducted?
This trial has 7 study locations across California, Colorado, Georgia, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.