Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT00450905
Status:
TERMINATED
Last Update Posted:
2008-10-06
First Post:
2007-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population
Sponsor:
Fralex Therapeutics
Organization:
Study Overview
Official Title:
Randomized Evaluation of a Low-Frequency Investigational Device Employing Neuromodulation Therapy in Patients With Fibromyalgia
Status:
TERMINATED
Status Verified Date:
2008-02
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:
This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: