Neurofilaments for NEDA Assessing in MS

NCT ID: NCT03250169

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-01-28

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Alemtuzumab

Licensed dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Mary University of London

London, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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011717

Identifier Type: -

Identifier Source: org_study_id

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