Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2025-12-17 @ 6:43 AM
Study NCT ID:
NCT04874155
Status:
None
Last Update Posted:
2024-10-08 00:00:00
First Post:
2021-05-03 00:00:00
Brief Title:
Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)
Sponsor:
Noctrix Health Inc
Organization:
Noctrix Health, Inc.
Study Overview
Official Title:
A Multi-Center, Randomized, Double-Blind, Sham-Controlled Study to Evaluate the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS) - The RESTFUL Study
Status:
None
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study consists of a series of two 4-week phases:
Phase 1: Prospective, double-blinded, 1:1 randomized (Active treatment: Sham control)
Phase 2: Prospective, non-randomized, non-blinded, Active treatment
Phase 1: Prospective, double-blinded, 1:1 randomized (Active treatment: Sham control)
Phase 2: Prospective, non-randomized, non-blinded, Active treatment
Detailed Description:
The study consists of a series of two 4-week phases
Phase 1 Prospective double-blinded 11 randomized Active treatment Sham control
Phase 2 Prospective non-randomized non-blinded Active treatment
Phase 1 Prospective double-blinded 11 randomized Active treatment Sham control
Phase 2 Prospective non-randomized non-blinded Active treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None