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NCT05196828 · ClinicalTrials.gov registry record · NA
Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
A NA study, sponsored by Noctrix Health.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT05196828: Completed NA study, sponsored by Noctrix Health.
NCT05196828 is a NA study that has completed, run by Noctrix Health. The registered enrollment target is 103 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05196828, a NA study, has completed, sponsored by Noctrix Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DEVICE NTX100 Neuromodulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2022-11-18 |
| Phase | NA |
What the finished NCT05196828 record still lists
NCT05196828 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which NTX100 Neuromodulation System is the first listed.
NCT05196828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05196828 about?
NCT05196828 is a clinical study titled "Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS". 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
What is the current status of trial NCT05196828?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2021-12-20. Estimated completion is 2022-11-18.
What interventions are being tested in trial NCT05196828?
The interventions under investigation include: NTX100 Neuromodulation System (DEVICE).
Who is sponsoring clinical trial NCT05196828?
This trial is sponsored by Noctrix Health, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05196828's enrollment target sits among peer trials
103 837th of 2000 higher than 1,164 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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