A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS (THRIVE)

• ClinicalTrials.gov Identifier: NCT06076499
• Recruitment Status: Recruiting
• First Posted: October 10, 2023
• Last Update Posted: February 21, 2024
• Sponsor: Noctrix Health, Inc.
• Information provided by (Responsible Party): Noctrix Health, Inc.

Tracking Information

• First Submitted Date: September 26, 2023
• First Posted Date: October 10, 2023
• Last Update Posted Date: February 21, 2024
• Actual Study Start Date: November 15, 2023
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2023)

Primary Effectiveness Endpoint [ Time Frame: 1 year ]

Change from baseline (study entry) in IRLS total score at 1-year.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 6, 2023)

• CGI-I score at 1-year relative to baseline [ Time Frame: 1 year ]
  The 1-year Clinical Global Impression-Improvement (CGI-I) score assesses a patient's overall condition relative to their baseline, indicating treatment effectiveness and change in condition over a year. Scores range from 1 (very much improved) to 7 (very much worse).
• PGI-I Score at 1-Year Relative to Baseline [ Time Frame: 1 year ]
  The 1-year Patient Global Impression-Improvement (PGI-I) score assesses the patient's perception of their condition's improvement from baseline, with scores ranging from 1 (very much improved) to 7 (very much worse).
• Change from baseline in MOS-II total score at 1-year. [ Time Frame: 1-year ]
  The Medical Outcomes Study 36-Item Short Form Health Survey (MOS-II) measures various aspects of a patient's health-related quality of life. This endpoint assesses the change in the total MOS-II score at the 1-year mark compared to the baseline, and how the treatment impacts overall well-being over the course of a year.
• Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year [ Time Frame: 1-year ]
  This endpoint focuses on Restless Legs Syndrome (RLS) and assesses the change in symptom frequency over a year. It quantifies the reduction in the number of days per week that a patient experiences RLS symptoms, indicating the treatment's effectiveness in managing this condition over time.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 6, 2023)

• CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 1-year. [ Time Frame: 1-year ]
  This metric gauges the proportion of patients showing significant improvement after one year of treatment, defined as a "Very Much Improved" or "Much Improved" CGI-I response.
• CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved". [ Time Frame: 1-year ]
  This measure indicates the percentage of patients experiencing positive change due to treatment, encompassing "Very Much Improved," "Much Improved," and "Minimally Improved" CGI-I responses.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS
• Official Title: A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix NTX100 TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study
• Brief Summary: Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.
• Detailed Description: This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings. Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: The study population will consist of adults who meet the inclusion and exclusion criteria.
• Condition: Restless Legs Syndrome

Intervention

Device: NTX100

NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.

• Study Groups/Cohorts: Not Provided

Publications *

• Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404.
• Charlesworth JD, Adlou B, Singh H, Buchfuhrer MJ. Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms. J Clin Sleep Med. 2023 Jul 1;19(7):1199-1209. doi: 10.5664/jcsm.10536.
• Bogan RK, Roy A, Kram J, Ojile J, Rosenberg R, Hudson JD, Scheuller HS, Winkelman JW, Charlesworth JD. Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial. Sleep. 2023 Oct 11;46(10):zsad190. doi: 10.1093/sleep/zsad190.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 6, 2023): 325
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. The 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.
2. The subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
3. Diagnosis of restless legs syndrome.

Exclusion Criteria:

1. The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators)
2. The subject has a metal implant at the site of the study device electrode application (not including knee replacements).

3. The subject has been diagnosed with one of the following conditions:

   • Epilepsy or other seizure disorder

4. The subject has a moderate or severe cognitive disorder or mental illness.
5. The subject has a known allergy to device materials (or a previous severe reaction to medical adhesives or bandages).

6. Subject has any of the following at or near the location of the device application:

   • Acute injury
   • Cellulitis
   • Open sores
7. The subject is unable or unwilling to comply with study requirements.
8. The subject is pregnant or trying to become pregnant

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Jessica Preciado, PhD; 5103331437; jessica@noctrixhealth.com

Contact: Jonathan D Charlesworth, PhD; 8046834279; jcharlesworth@noctrixhealth.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06076499
• Other Study ID Numbers: CT-06
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Noctrix Health, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Noctrix Health, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jessica Preciado, PhD; Noctrix Health, Inc.

• PRS Account: Noctrix Health, Inc.
• Verification Date: February 2024