NCT03250169

Neurofilaments for NEDA Assessing in MS

Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: —

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Alemtuzumab	Licensed dose

Timeline

• Start date: 2017-08-01
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2017-08-15
• Last updated: 2022-02-25

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study