Neurofilaments for NEDA Assessing in MS

Terminated

• Conditions: Multiple Sclerosis

• Registration Number: NCT03250169
• Lead Sponsor: Queen Mary University of London

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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-19
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Primary Completion: 2022-01-28
• Study Completion: 2022-01-28
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
2. Age 18-55 years.
3. EDSS score between 0-5.5.
4. Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D

Exclusion Criteria

1. A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
2. Those unable to comply with study requirement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood and CSF neurofilaments in Alemtuzumab patients over 24months	2 years	Neurofilaments

Secondary Outcome Measures

Name	Time	Method
Overall clinical response based on neurofilament response	2 years	neurofilaments
Longitudinal assessment of other biomarkers of inflammation & plasticity	2 years	Correlation index
Neurofilament status and association with clinical and MRI markers of disease activity.	2 years	Correlation index

Trial Locations

Locations (1)

Queen Mary University of London; 🇬🇧 London, England, United Kingdom