CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 133 enrolled
Drug / intervention
NTX100 Neuromodulation System - Active +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04874155
NCT04874155N/ACompleted
CompareCT.gov

A Multi-Center, Randomized, Double-Blind, Sham-Controlled Study to Evaluate the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS) - The RESTFUL Study

Noctrix Health, Inc.·interventional·Posted May 5, 2021·Updated Oct 8, 2024

In Brief

A clinical study evaluating NTX100 Neuromodulation System - Active, NTX100 Neuromodulation System - Sham, and 1 other intervention for Restless Legs Syndrome. Completed, enrolled 133 participants across 7 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 5, 2021
Enrollment StartMay 6, 2021
Primary CompletionMar 18, 2022
Study CompletionApr 8, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.2 years ago

Interventions

NTX100 Neuromodulation System - Activedevice

Noninvasive peripheral nerve stimulation device programmed to active mode.

NTX100 Neuromodulation System - Shamdevice

Noninvasive peripheral nerve stimulation device programmed to sham mode.

NTX100 Neuromodulation System - Open-Labeldevice

Noninvasive peripheral nerve stimulation device programmed to active mode.