Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-03-17 @ 10:42 PM
Study NCT ID:
NCT03250169
Status:
TERMINATED
Last Update Posted:
2022-02-25
First Post:
2017-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofilaments for NEDA Assessing in MS
Sponsor:
Queen Mary University of London
Organization:
Study Overview
Official Title:
Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Under recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.
Detailed Description:
Primary
1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.
Secondary
2. To assess prognosis at the end of the study based on neurofilament status.
3. To correlate neurofilament levels with clinical and MRI markers of disease activity.
4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.
1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.
Secondary
2. To assess prognosis at the end of the study based on neurofilament status.
3. To correlate neurofilament levels with clinical and MRI markers of disease activity.
4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: