Neurofilaments for NEDA Assessing in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03250169
• Other study ID #: 011717
• Status: Terminated
• Start date: August 1, 2017
• Est. completion date: January 28, 2022

Study information

• Verified date: July 2017
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Alemtuzumab
Licensed dose

Locations

Country	Name	City	State
United Kingdom	Queen Mary University of London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood and CSF neurofilaments in Alemtuzumab patients over 24months	Neurofilaments	2 years
Secondary	Overall clinical response based on neurofilament response	neurofilaments	2 years
Secondary	Neurofilament status and association with clinical and MRI markers of disease activity.	Correlation index	2 years
Secondary	Longitudinal assessment of other biomarkers of inflammation & plasticity	Correlation index	2 years