NCT05196828

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Noctrix Health, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DEVICE	NTX100 Neuromodulation System	Active Noninvasive peripheral nerve stimulation device programmed to active mode

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-09-27
• Completion: 2022-11-18
• First posted: 2022-01-19
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study