← Back to Search

Behavioural Intervention

Noninvasive Peripheral Nerve Stimulation (NPNS) for Restless Legs Syndrome

N/A
Waitlist Available
Research Sponsored by Noctrix Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week into step-down #2
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a nerve-stimulating device can help patients with severe RLS reduce their opioid use without worsening their symptoms.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week into step-down #2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week into step-down #2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Subjects Without a Clinically Significant Increase in RLS Symptoms During the First Phase Involving an Opioid Dose Reduction of >= 20% Relative to Baseline.
Secondary study objectives
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score During Step-down #1 With an Opioid Dose Reduction of >=20%
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score During Step-down #2 With an Opioid Dose Reduction of >=1/3
Maximum Percent Change in Opioid Dose Relative to Baseline Without a Clinically Significant Increase in RLS Symptoms.
+1 more
Other study objectives
NPNS Adherence Ratio During Step-down #1 and Step-down #2.
NPNS Tolerability Rate - Percentage of Subjects Who Withdrew From Optional Phase 3 Citing Lack of Tolerability of NPNS as the Primary Reason for Withdrawal.
Percentage of Grade 2 or Higher NPNS-related Adverse Events.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Noninvasive Peripheral Nerve Stimulation (NPNS)Experimental Treatment1 Intervention
NPNS device programmed to deliver active stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Noninvasive Peripheral Nerve Stimulation (NPNS)
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Noctrix Health, Inc.Lead Sponsor
5 Previous Clinical Trials
662 Total Patients Enrolled
5 Trials studying Restless Legs Syndrome
662 Patients Enrolled for Restless Legs Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,377 Previous Clinical Trials
651,816 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
199 Patients Enrolled for Restless Legs Syndrome
Jonathan D Charlesworth, PhDStudy DirectorNoctrix Health, Inc.
4 Previous Clinical Trials
337 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
337 Patients Enrolled for Restless Legs Syndrome
~5 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top