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NCT04698343 · ClinicalTrials.gov registry record · NA
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction
A NA study of Restless Legs Syndrome, sponsored by Noctrix Health.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT04698343: Completed NA study of Restless Legs Syndrome, sponsored by Noctrix Health.
NCT04698343 is a NA study of Restless Legs Syndrome that has completed, run by Noctrix Health. The registered enrollment target is 21 participants, below the 95-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04698343, a NA study of Restless Legs Syndrome, has completed, sponsored by Noctrix Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
Prospective open-label single-arm feasibility study assessing the tolerability of opioid medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for patients taking prescription opioids to treat moderate-severe primary RLS.
Primary Outcome
Percentage of subjects without a clinically significant increase in RLS symptoms during the first Phase involving an opioid dose reduction of \>= 20% relative to baseline. The clinically significant increase was assessed by determining the Clinician Global Impression of Improvement (CGI-I) score for the subject. Possible choices (followed by scale value) are: Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Minimally worse (5), Much worse (6), Very Much Worse (7)
Conditions Studied
Interventions
- DEVICE Noninvasive Peripheral Nerve Stimulation (NPNS)
Study Locations (2)
California
- Mark J Buchfuhrer private practice - Downey
Ohio
- Ohio Sleep Medicine Institute - Dublin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2023-03-28 |
| Phase | NA |
What the finished NCT04698343 record still lists
NCT04698343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 95-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Restless Legs Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Noninvasive Peripheral Nerve Stimulation (NPNS) is the first listed.
NCT04698343 reports a single indexed study location in California, Ohio.
Frequently Asked Questions
What is clinical trial NCT04698343 about?
NCT04698343 is a clinical study titled "Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction". Prospective open-label single-arm feasibility study assessing the tolerability of opioid medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for patients taking prescription opioids to treat moderate-severe primary RLS.
What is the current status of trial NCT04698343?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2021-04-06. Estimated completion is 2023-03-28.
What conditions does trial NCT04698343 study?
This clinical trial studies the following conditions: Restless Legs Syndrome.
What interventions are being tested in trial NCT04698343?
The interventions under investigation include: Noninvasive Peripheral Nerve Stimulation (NPNS) (DEVICE).
Who is sponsoring clinical trial NCT04698343?
This trial is sponsored by Noctrix Health, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04698343 being conducted?
This trial has 2 study locations across California, 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 NCT04698343's enrollment target sits among peer trials
21 13th of 14 higher than 2 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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