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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: Completed NA study of Restless Legs Syndrome, sponsored by Noctrix Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the investigator-rated 7-point CGI-I scale.
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 |
What the finished NCT04874155 record still lists
NCT04874155 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (53% higher).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Restless Legs 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 NCT04874155's enrollment target sits among peer trials
133 3rd of 14 higher than 12 of 14 other Restless Legs Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Restless Legs 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
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Blood Changes After Exercise in Restless Legs Syndrome
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Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
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-
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ACTIVE NOT RECRUITING
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