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NCT06076499 · ClinicalTrials.gov registry record

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

A clinical trial of Restless Legs Syndrome, sponsored by Noctrix Health.

Active
Registry status
325
Enrollment target
6
Study locations

NCT06076499: Active study of Restless Legs Syndrome, sponsored by Noctrix Health.

NCT06076499 is a study of Restless Legs Syndrome that is active but no longer recruiting, run by Noctrix Health. The registered enrollment target is 325 participants, above the 73-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (345% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06076499, a study of Restless Legs Syndrome, is active but no longer recruiting, sponsored by Noctrix Health.

ACTIVE NOT RECRUITING
Registry status
325 participants
Enrollment target
6
Study locations

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.

Primary Outcome

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

Conditions Studied

Interventions

  • DEVICE NTX100

Study Locations (6)

California

  • Mark J Buchfuhrer, MD Office - Downey
  • Sleep Medicine Specialists of California - San Ramon

Massachusetts

  • Neurocare, Inc. - Newton

Missouri

  • Clayton Sleep Institute - St Louis

Ohio

  • Ohio Sleep Medicine and Institute - Dublin

South Carolina

  • Bogan Sleep Consultants, LLC - Columbia

Trial Details

FieldValue
Enrollment Target 325 participants
Start Date 2023-11-15
Est. Completion 2026-12
Noctrix Health

8 total trials

What the registry record for NCT06076499 still lists

NCT06076499 is an observational study that tracks outcomes without assigning an intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (345% higher).

The record links to 1 condition, with Restless Legs Syndrome appearing as the primary indexed condition, and to 1 intervention - of which NTX100 is the first listed.

NCT06076499 lists 6 locations in 5 states (California, Massachusetts, Missouri).

Frequently Asked Questions

What is clinical trial NCT06076499 about?

NCT06076499 is a clinical study titled "A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS". 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.

What is the current status of trial NCT06076499?

This trial is currently active not recruiting. The enrollment target is 325 participants. The study started on 2023-11-15. Estimated completion is 2026-12.

What conditions does trial NCT06076499 study?

This clinical trial studies the following conditions: Restless Legs Syndrome.

What interventions are being tested in trial NCT06076499?

The interventions under investigation include: NTX100 (DEVICE).

Who is sponsoring clinical trial NCT06076499?

This trial is sponsored by Noctrix Health, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06076499 being conducted?

This trial has 6 study locations across California, Massachusetts, Missouri, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Restless Legs Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06076499's enrollment target sits among peer trials

325 2nd of 14 the highest of 14 other Restless Legs Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Restless Legs Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06076499, the US trial registry maintained by the National Library of Medicine. NCT06076499 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.