At a glance
ClinicalIndex Comparison RecordN/ACompleted· 103 enrolled
Drug / intervention
NTX100 Neuromodulation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label Extension Study to Evaluate Longer-Duration Response to the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS)
In Brief
A clinical study evaluating NTX100 Neuromodulation System for Restless Legs Syndrome. Completed, enrolled 103 participants across 7 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartDec 2021
First PostedJan 2022
Primary CompletionSep 2022
Study CompletionNov 2022
TodayJul 2026
First PostedJan 19, 2022
Enrollment StartDec 20, 2021
Primary CompletionSep 27, 2022
Study CompletionNov 18, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.5 years ago
Interventions
NTX100 Neuromodulation Systemdevice
Active Noninvasive peripheral nerve stimulation device programmed to active mode