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

NCT05196828 | Completed Results FDA Device

• 1 other identifier: CT-05
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment Group (Arm 1) Relative to Baseline.

  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. The outcomes were also evaluated as Treatment Group (Arm 1) at 24 weeks related to Control Group (Arm 2) at 24 weeks. The primary outcome, however, is the measure relative to baseline.

  Week 24

Secondary Outcomes (5)

• Number of Subjects That Report "Much Improved" or "Very Much Improved" on the Patient Global Impressions-Improvement (PGI-I) Scale in the Treatment Group (Arm 1) Relative to Baseline.

  Week 24

• Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1

  Week 24

• Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score in Arm 1

  Week 24

• Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score in Arm 1

  Week 24

• Days Per Week of RLS Symptoms Based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1

  Week 24

Study Arms (2)

Arm 1 - Direct Roll-Over Extension

ACTIVE COMPARATOR

24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention

Device: NTX100 Neuromodulation System

Arm 2 - Control Group

NO INTERVENTION

24-wks of No Intervention

Interventions

NTX100 Neuromodulation System DEVICE

Active Noninvasive peripheral nerve stimulation device programmed to active mode

Arm 1 - Direct Roll-Over Extension

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject previously completed the RESTFUL Study (NCT04874155).
• Subject has signed a valid, Institutional Review Board-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
• \[applicable to Arm 1 only\] 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.

You may not qualify if:

• \[applicable to Arm 1 only\] 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 at the site of study device electrode application.
• \[applicable to Arm 1 only\] Subject has been diagnosed with one of the following conditions:
• Epilepsy or other seizure disorder Current, active or acute or chronic infection other than common cold \[and except for acute infections with mild symptoms\]
• A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
• Stage 4-5 chronic kidney disease or renal failure
• Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)
• Deep vein thrombosis
• Multiple sclerosis
• Subject has moderate or severe cognitive disorder or mental illness.
• \[applicable to Arm 1 only\] Subject has known allergy to device materials, electrode gel, polyurethane foam, or lycra (or severe previous reaction to medical adhesives or bandages).
• \[applicable to Arm 1 only\] Subject has severe edema affecting lower legs.
• \[applicable to Arm 1 only\] Subject has any of the following at or near the location of device application.
• Acute injury
• Cellulitis
• Open sores

Sponsors & Collaborators

• Noctrix Health, Inc.: lead

Study Sites (7)

California Center for Sleep Disorders

San Leandro, California, 94578, United States

Location

Delta Waves, Inc.

Colorado Springs, Colorado, 95125, United States

Location

Neurotrials Research

Atlanta, Georgia, 30328, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Related Publications (1)

• Roy A, Ojile J, Kram J, Olin J, Rosenberg R, Hudson JD, Bogan RK, Charlesworth JD. Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. Sleep. 2023 Oct 11;46(10):zsad188. doi: 10.1093/sleep/zsad188.

  PMID: 37439365 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: Jonathan Charlesworth, PhD
• Organization: Noctrix Health, Inc.

jcharlesworth@noctrixhealth.com

804-683-4279

Study Officials

• Jonathan D Charlesworth, PhD

  Noctrix Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 19, 2022
• Study Start: December 20, 2021
• Primary Completion: September 27, 2022
• Study Completion: November 18, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (7)