Neurofilaments for NEDA Assessing in MS

Queen Mary University of London

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Drug: Alemtuzumab

Study type: Observational

Funder types: Other

Identifiers

NCT03250169

011717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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