A Multi-Center, Randomized, Double-Blind, Sham-Controlled Study to Evaluate the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS) - The RESTFUL Study

Noctrix Health, Inc.7 sites in 1 country133 target enrollmentMay 6, 2021

ConditionsRestless Legs Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Restless Legs Syndrome
Sponsor: Noctrix Health, Inc.
Enrollment: 133
Locations: 7
Primary Endpoint: Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale for TOMAC Compared to Sham
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary RLS

Detailed Description

The study consists of a series of two 4-week phases: Phase 1: Prospective, double-blinded, 1:1 randomized (Active treatment: Sham control) Phase 2: Prospective, non-randomized, non-blinded, Active treatment

Registry

clinicaltrials.gov

Start Date

May 6, 2021

End Date

April 8, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Noctrix Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has received a medical diagnosis of primary restless legs syndrome (RLS).
•Subject is refractory to RLS medication (as defined in section 7.3).
•Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale \[12\]) over the week prior to study entry.
•Subject has RLS symptoms 2 or more nights per week during the week prior to study entry as defined by a score of 2, 3, or 4 on IRLS question #
•RLS symptoms are most significant in the subject's lower legs and/or feet.
•RLS symptoms are most significant at bedtime, after bedtime, and/or in the 2 hours before bedtime.
•RLS symptoms between 10am and 6pm are not severe.
•Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.
•Subject agrees to not make major lifestyle changes during the study including diet, exercise, career, or other changes that would affect bedtime.
•Subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.

Exclusion Criteria

•Subject has RLS that is known to be caused by another diagnosed condition (i.e. secondary RLS).
•Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms, such as antidepressants, sleep medications, or sedative antihistamines or has changed dosage within the past 30 days.
•Subject has changed dose and schedule of RLS medications within the month prior to study entry or is otherwise on an inconsistent dose or schedule of RLS medications.
•Subject reports having significant prior experience with neurostimulation devices (including but not limited to TENS devices) or subject has prior experience with neurostimulation devices developed by the study sponsor.
•Subject was misdiagnosed with RLS, as determined by the investigator (e.g. actual diagnosis of PLMD, arthritis, leg spasms or neuropathy without comorbid RLS).
•Subject has a sleep disorder other than RLS that interferes with sleep at the present time (except for obstructive sleep apnea that is stably controlled via CPAP).
•Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant in the leg.
•Subject has failed a nerve conduction study prescribed by a physician or has been diagnosed with severe peripheral neuropathy.
•Subject reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
•On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min.

Outcomes

Primary Outcomes

Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale for TOMAC Compared to Sham

Time Frame: Week 4

Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the investigator-rated 7-point CGI-I scale.

Secondary Outcomes

Responder Rate on Patient Global Impressions-Improvement (PGI-I) Scale(Week 4)
Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score(Week 4)
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score(Week 4)
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score(Week 4)
Mean Clinical Global Impressions-Improvement (CGI-I) Scale Rating(Week 4)
Score for Question #7 of the International Restless Legs Syndrome Study Group Rating Scale (IRLS)(Week 8)