Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01112657
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2010-03-10
Brief Title:
An Observational Study on the Progression of Clinically Isolated Syndrome to Multiple Sclerosis Over a 2-year Period
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Prospective Observational Study On The Progression Of Clinically Isolated Syndrome CIS To Multiple Sclerosis Over A 2-year Period
Status:
COMPLETED
Status Verified Date:
2014-11
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:
NEO
Brief Summary:
This is a prospective multicentric observational study with a 2 years recruitment period The purpose of the study is to observe the multiple sclerosis MS progression of subjects since their first episode of neurological event and secondly to determine status of anti-AQP4 immunoglobulin IgG antibody in MS subjects
Detailed Description:
Multiple sclerosis is chronic inflammatory disease of the central nervous system CNS characterised by areas of demyelination or plaques in the CNS In 85 of subjects who later develop MS clinical onset is with an acute or subacute episode of neurological disturbance due to a single white-matter lesion eg optic neuritis or an isolated brainstem or partial spinal-cord syndrome This presentation is known as a Clinically Isolated Syndrome CIS Because a CIS is typically the earliest clinical expression of MS research on subjects with a CIS may provide new insights into early pathological changes and pathogenetic mechanisms that might affect the course of the disorder
In the group of subjects with optic-spinal MS OSMS the main lesions are typically confined to the optic nerve and spinal cord In Asians OSMS has similar features to the relapsing remitting form of neuromyelitis optica NMO seen in Westerners It is still a matter of debate whether NMO represents a disease entity in itself or whether it is a subform of MS Early differentiation of NMO from MS is highly desirable as treatment options and prognoses differ widely Recently a new serum autoantibody NMO-IgG has been detected in NMO subjects The binding sites of this autoantibody were reported to colocalize with aquaporin 4 AQP4 water channels Optic-spinal MS is sometime suggested to be NMO based on the frequent detection of the anti-AQP4 IgG antibody In Taiwan study has shown that 56 of MS subjects were of the optic-spinal type
OBJECTIVES
The study is designed firstly to observe the MS progression of subjects since their first episode of neurological event and secondly to determine status of anti-AQP4 IgG antibody in MS subjects
Primary objective
To describe the progression of subjects who have experienced a CIS to MS over a 2-year period
Secondary objectives
To assess the relationship between CIS and MS including optic-spinal MS OSMS
To determine the status of anti-AQP4 IgG antibody in subjects who convert to MS
Each subject shall be followed up for 2 years after enrolment At baseline routine examinations shall be performed to confirm subjects neurological episode After the baseline visit the subject shall be instructed to return for further examination if heshe experiences a relapse During the follow-up examinations the treating physician shall determine whether the subject fulfil the diagnostic criteria for MS
If subject is being diagnosed with MS heshe shall be considered as reaching the end of hisher study participation Further management of the MS condition will be at the discretion of the treating physician During 2-year follow-up period telephone calls to the subject shall be made quarterly to assess subjects neurological andor visual status and to remind subject that heshe need to return for evaluation in the event of a relapse All data will be collected using a standardised case report form CRF
In the group of subjects with optic-spinal MS OSMS the main lesions are typically confined to the optic nerve and spinal cord In Asians OSMS has similar features to the relapsing remitting form of neuromyelitis optica NMO seen in Westerners It is still a matter of debate whether NMO represents a disease entity in itself or whether it is a subform of MS Early differentiation of NMO from MS is highly desirable as treatment options and prognoses differ widely Recently a new serum autoantibody NMO-IgG has been detected in NMO subjects The binding sites of this autoantibody were reported to colocalize with aquaporin 4 AQP4 water channels Optic-spinal MS is sometime suggested to be NMO based on the frequent detection of the anti-AQP4 IgG antibody In Taiwan study has shown that 56 of MS subjects were of the optic-spinal type
OBJECTIVES
The study is designed firstly to observe the MS progression of subjects since their first episode of neurological event and secondly to determine status of anti-AQP4 IgG antibody in MS subjects
Primary objective
To describe the progression of subjects who have experienced a CIS to MS over a 2-year period
Secondary objectives
To assess the relationship between CIS and MS including optic-spinal MS OSMS
To determine the status of anti-AQP4 IgG antibody in subjects who convert to MS
Each subject shall be followed up for 2 years after enrolment At baseline routine examinations shall be performed to confirm subjects neurological episode After the baseline visit the subject shall be instructed to return for further examination if heshe experiences a relapse During the follow-up examinations the treating physician shall determine whether the subject fulfil the diagnostic criteria for MS
If subject is being diagnosed with MS heshe shall be considered as reaching the end of hisher study participation Further management of the MS condition will be at the discretion of the treating physician During 2-year follow-up period telephone calls to the subject shall be made quarterly to assess subjects neurological andor visual status and to remind subject that heshe need to return for evaluation in the event of a relapse All data will be collected using a standardised case report form CRF
Study Oversight
Has Oversight DMC:
None
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?:
None