Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT06076499
Active, not recruiting Observational

A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS

NCT06076499 · tracked via the Priya Life Science USA tracker
Sponsor
Noctrix Health, Inc
Phase
Observational
Started
2023-11-15
Last updated
2026-05-27

Condition(s) studied

Restless Legs Syndrome

Investigational drug(s) / intervention(s)

NTX100

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

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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 is unable or unwilling to comply with study requirements.

Primary outcome measure(s)

  • Primary Effectiveness Endpoint — 1 year
    Change from baseline (study entry) in IRLS total score at 1-year.

Trial sites (7)

FacilityCityRegionStatus
Mark J Buchfuhrer, MD Office Downey California
Sleep Medicine Specialists of California San Ramon California
Neurocare, Inc. Newton Massachusetts
Clayton Sleep Institute St Louis Missouri
Ohio Sleep Medicine and Institute Dublin Ohio
University of Pittsburgh Pittsburgh Pennsylvania
Bogan Sleep Consultants, LLC Columbia South Carolina

More Noctrix Health, Inc. trials in the USA

Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS) Recruiting
Response to an Investigational Device in Patients With Restless Legs Syndrome Active, not recruiting

Other trials for the same condition

Response to an Investigational Device in Patients With Restless Legs Syndrome Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06076499 on ClinicalTrials.gov ↗ ← All trials in the USA