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Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS

Restless Legs Syndrome Clinical Trial

Official title:
Open-label Extension Study to Evaluate Longer-Duration Response to the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS)

Clinical Trial Summary

Multi-center, prospective open-label extension study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate- severe primary RLS

Clinical Trial Description

This is an extension study only inviting subjects who have previously completed the RESTFUL Study (NCT04874155). Each study subject is enrolled into one of the following Arms: Arm 1 (Direct Roll-Over Extension): 24-week open-label NPNS followed by 8-weeks of no treatment, no delay after completion of the RESTFUL Study Arm 2 (Control Group): 24-weeks of no treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05196828
Study type Interventional
Source Noctrix Health, Inc.
Contact
Status Completed
Phase N/A
Start date December 20, 2021
Completion date November 18, 2022
View Details
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