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NCT05214963 · ClinicalTrials.gov registry record · NA

Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS

A NA study, sponsored by Noctrix Health.

Completed
Registry status
NA
Development phase
58
Enrollment target

NCT05214963: Completed NA study, sponsored by Noctrix Health.

NCT05214963 is a NA study that has completed, run by Noctrix Health. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05214963, a NA study, has completed, sponsored by Noctrix Health.

COMPLETED
Registry status
NA
Development phase
58 participants
Enrollment target

Study Summary

Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.

Primary Outcome

Percentage of subjects who withdraw from study citing lack of tolerability of the study device as the primary reason for withdrawal

Interventions

  • DEVICE NTX100 Neuromodulation System - Active
  • DEVICE NTX100 Neuromodulation System - Sham

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2022-03-08
Est. Completion 2023-10-24
Phase NA
Noctrix Health

8 total trials

What the finished NCT05214963 record still lists

NCT05214963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which NTX100 Neuromodulation System - Active is the first listed.

NCT05214963 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05214963 about?

NCT05214963 is a clinical study titled "Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS". Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.

What is the current status of trial NCT05214963?

This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2022-03-08. Estimated completion is 2023-10-24.

What interventions are being tested in trial NCT05214963?

The interventions under investigation include: NTX100 Neuromodulation System - Active (DEVICE), NTX100 Neuromodulation System - Sham (DEVICE).

Who is sponsoring clinical trial NCT05214963?

This trial is sponsored by Noctrix Health, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05214963's enrollment target sits among peer trials

58 1256th of 2000 higher than 740 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT05214963, the US trial registry maintained by the National Library of Medicine. NCT05214963 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.