Neurofilaments for NEDA Assessing in MS
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ClinicalTrials.gov Identifier: NCT03250169 |
Recruitment Status : Unknown
Verified July 2017 by Queen Mary University of London.
Recruitment status was: Recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
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Condition or disease | Intervention/treatment |
---|---|
Multiple Sclerosis | Drug: Alemtuzumab |
Primary
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To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.
Secondary
- To assess prognosis at the end of the study based on neurofilament status.
- To correlate neurofilament levels with clinical and MRI markers of disease activity.
- 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 Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | July 1, 2020 |
Estimated Study Completion Date : | July 1, 2020 |

- Drug: Alemtuzumab
Licensed dose
- Blood and CSF neurofilaments in Alemtuzumab patients over 24months [ Time Frame: 2 years ]Neurofilaments
- Overall clinical response based on neurofilament response [ Time Frame: 2 years ]neurofilaments
- Neurofilament status and association with clinical and MRI markers of disease activity. [ Time Frame: 2 years ]Correlation index
- Longitudinal assessment of other biomarkers of inflammation & plasticity [ Time Frame: 2 years ]Correlation index

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
- Age 18-55 years.
- EDSS score between 0-5.5.
- Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D
Exclusion Criteria:
- A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
- Those unable to comply with study requirement

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250169
Contact: Francesca Ammoscato | 02078822282 | f.ammoscato@qmul.ac.uk |
United Kingdom | |
Queen Mary University of London | Recruiting |
London, England, United Kingdom, E1 2AT | |
Contact: Francesca Ammoscato f.ammoscato@qmul.ac.uk |
Responsible Party: | Queen Mary University of London |
ClinicalTrials.gov Identifier: | NCT03250169 |
Other Study ID Numbers: |
011717 |
First Posted: | August 15, 2017 Key Record Dates |
Last Update Posted: | August 15, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Alemtuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |