Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918421
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2019-04-15
Brief Title:
Immunoglobulin M IgM-Anti-myelin-associated-glycoproteinMAG Peripheral Neuropathy Study
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Immunoglobulin M IgM-Anti-myelin-associated-glycoproteinMAG Peripheral Neuropathy Study From Proper Assessment to Trial Needs - IMAGiNe Study-LyonBicêtre
Status:
RECRUITING
Status Verified Date:
2023-11
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:
There is no international consensus regarding how to assess and treat patients with immunoglobulin M IgM-anti-myelin-associated-glycoprotein MAG monoclonal gammopathy associated peripheral neuropathy The purpose of the IMAGiNe study-LyonBicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study
The main objective is to describe in detail the various clinical subtypes clinical course treatment responses antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale RODS that should fulfill all modern clinimetric requirements including cross-cultural validity The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht both in the Netherlands
The main objective is to describe in detail the various clinical subtypes clinical course treatment responses antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale RODS that should fulfill all modern clinimetric requirements including cross-cultural validity The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht both in the Netherlands
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A00884-53 | OTHER | ID-RCB | None |