Multiple SclerosisNCT03250169
Neurofilaments for NEDA Assessing in MS
An observational study of Multiple Sclerosis, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Alemtuzumab
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2017to 28 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: Relapsing-remitting MS
Who may be able to join
- 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
Who cannot join
- A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
- Those unable to comply with study requirement
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Mary University of London
London, England, E1 2AT
About this study
Official title: Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study
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.
Read the detailed description
Primary
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Alemtuzumab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
Licensed dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and CSF neurofilaments in Alemtuzumab patients over 24months
Neurofilaments
Measured: 2 years
Secondary outcomes (3)
Overall clinical response based on neurofilament response
neurofilaments
Measured: 2 years
Neurofilament status and association with clinical and MRI markers of disease activity.
Correlation index
Measured: 2 years
Longitudinal assessment of other biomarkers of inflammation & plasticity
Correlation index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Aug 2017
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Why it stopped: Under recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250169
- Sponsor's protocol ID
- 011717
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study
- ClinicalTrials.gov ID
- NCT03250169
- Acronym / sponsor ID
- 011717
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Under recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Relapsing-remitting MS
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.
- Those unable to comply with study requirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlemtuzumabLicensed dose | Drug | – |
Primary outcome
Blood and CSF neurofilaments in Alemtuzumab patients over 24months
Time frame: 2 years
Neurofilaments
3 secondary outcomes
Overall clinical response based on neurofilament response
Time frame: 2 years
Neurofilament status and association with clinical and MRI markers of disease activity.
Time frame: 2 years
Longitudinal assessment of other biomarkers of inflammation & plasticity
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Under recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Under recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood and CSF neurofilaments in Alemtuzumab patients over 24months (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.