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
Restless Leg Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week into step-down #2

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.

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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.

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