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

NCT05196828 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2024-09-19

Study results available
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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

Conditions

  • Restless Legs Syndrome

Interventions

DEVICE

NTX100 Neuromodulation System

Active Noninvasive peripheral nerve stimulation device programmed to active mode

Sponsors & Collaborators

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan D Charlesworth, PhD · Noctrix Health, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2022-09-27
Completion
2022-11-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196828 on ClinicalTrials.gov