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Multiple SclerosisNCT03806387

Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment

An observational study of Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple Sclerosis (MS) is a chronic autoimmune neurodegenerative disease of the central nervous system (CNS). The symptoms of MS are wide-ranging, but patients perceive loss of physical function (gait) and cognitive function as the most critical consequences of the disease. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Alemtuzumab
How many people
17 participants
Where
1 siteDenmark
Study dates
1 Mar 2017to 30 Jun 2021
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Multiple Sclerosis patients will be recruited from MS clinics all over Denmark.

Who may be able to join

  • Clinical definite Multiple Sclerosis diagnosis according to the McDonald criteria
  • About to commence alemtuzumab (Lemtrada) treatment
  • Expanded Disability Status Scale (EDSS) ≤ 5.5
  • Signed informed consent

Who cannot join

  • Co-morbidities that prevent participation in the project (dementia, serious cognitive disorders etc.)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University, Health, Section for Sport Science

    Aarhus, Jutland, 8000

Other trials in Denmark

About this study

Official title: Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study

Multiple Sclerosis (MS) is a chronic autoimmune neurodegenerative disease of the central nervous system (CNS). The symptoms of MS are wide-ranging, but patients perceive loss of physical function (gait) and cognitive function as the most critical consequences of the disease. Moreover, recent studies have shown that already at early disease stages functional impairments are present.

One of the more recent approved medical treatments for MS patients is Alemtuzumab (product name Lemtrada), a humanized monoclonal antibody targeting CD52 cells, that depletes and repopulates B lymphocytes and T lymphocytes, causing sustained changes in the adaptive immunity. In 2013 and 2014 Alemtuzumab was approved in EU and USA, respectively.

Read more

With the exception of the MS Functional Composite z-score, the previous clinical studies investigating the effect of Alemtuzumab have exclusively focused on clinical parameters such as MRI indications of disease activity (accumulation of lesion, total and regional brain atrophy etc.), relapse-rates, changes in 'expanded disability status scale' (EDSS) and side-effects/adverse events. However, no previous studies have performed in depth monitoring on how physical or cognitive performance are affected following initiation of treatment with Alemtuzumab despite the paramount importance to patients.

The primary purpose of this project is to monitor the changes in physical performance during the first two years of treatment with Alemtuzumab in a well characterised Danish cohort of people with relapsing-remitting MS. A secondary purpose is to monitor the impact of Alemtuzumab treatment on cognition during the first two years of treatment.

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

    Also called Lemtrada

    Alemtuzumab will be given two times, separated by 1 year.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six minute walking test (6MWT)

    Change in maximal walking distance covered in 6 minutes

    Measured: From baseline to 24 months

Secondary outcomes (22)

  1. Six minute walking test (6MWT)

    Change in maximal walking distance covered in 6 minutes

    Measured: From baseline to 3 months, 6 months, and 12 months

  2. Timed 25 foot walk (T25FWT)

    Change in maximal walking speed

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  3. 5 times sit to stand test (5STS)

    Change in time to perform 5 times sit to stand test (5STS)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  4. Timed Up and Go (TUG)

    Change in time to perform Timed Up and Go (TUG)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  5. Stair Climbing test

    Change in time to perform 9-step stair climbing

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  6. Six Spot Step Test (SSST)

    Change in maximal walking speed while challenging coordination/balance

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  7. Maximal oxygen uptake (VO2 max)

    Change in aerobic power

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  8. Maximal muscle strength

    Change in isometric and dynamic knee extensor muscle strength, isometric hand grip strength

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  9. Neuromuscular activation

    Change in neural drive during maximal isometric knee extension

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  10. Body composition - limb lean mass

    Change in total lower limb lean mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  11. Body composition - limb fat mass

    Change in total lower limb fat mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  12. Body composition - whole body lean mass

    Change in total body lean mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  13. Body composition - whole body fat mass

    Change in total body fat mass (kg) (assessed by Dual-energy X-ray Absorptiometry - DXA scan).

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  14. Selective Reminding Test (SRT)

    Change in cognitive test assessing memory

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  15. Symbol Digit Modalities Test (SDMT)

    Change in cognitive test assessing processing speed

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  16. Physical activity

    Change in accelerometer-based assessment of 24-hour physical activity

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  17. Clinical Severity of Disease

    Estimation of disease severity by the Expanded Disability Severity Scale (EDSS scores: best 0 = normal neurological exam, worst 10 = death due to multiple sclerosis)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  18. Relapse frequency

    Number of relapses

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  19. 12-item Multiple Sclerosis Walking Scale (MSWS-12)

    Self-reported questionnaire assessing impact of MS on walking ability (MSWS-12 scores: best 0, worst 100)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  20. Modified Fatigue Impact Scale (MFIS)

    Self-reported questionnaire assessing impact of MS-induced fatigue on a persons life (MFIS total scores: best 0, worst 84; physical subscale scores: best 0, worst 36; cognitive subscale scores: best 0, worst 40; psychosocial subscale scores: best 0, worst 8)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  21. Multiple Sclerosis Impact Scale (MSIS-29)

    Self-reported questionnaire assessing impact of MS on day-to-day life, from a physical perspective (MSIS-29 physical scale: best 0, worst 100 (greater impact of disease on daily function = worse health) and from a psychological perspective (MSIS-29 psychological scale: best 0, worst 100 (greater impact of disease on daily function = worse health)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

  22. Hospital Anxiety and Depression Scale (HADS)

    Self-reported questionnaire assessing impact of MS on anxiety (scores: best 0, worst 21) and depression (scores: best 0, worst 21)

    Measured: From baseline to 3 months, 6 months, 12 months, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start1 Mar 2017
  3. Primary completion30 Jul 2020
  4. Study completion30 Jun 2021

Resources

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806387
Sponsor's protocol ID
MS_Improve
Status last verified
Mar 2021
First submitted
9 Jan 2019
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hvid LG, Stenager E, Dalgas U. Objectively assessed physiological, physical, and cognitive function along with patient-reported outcomes during the first 2 years of Alemtuzumab treatment in multiple sclerosis: a prospective observational study. J Neurol. 2022 Sep;269(9):4895-4908. doi: 10.1007/s00415-022-11134-7. Epub 2022 Apr 28.

    PubMed 35482080

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.

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 1 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: finished, as of the sponsor's last update on 6 Sep 2023. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Six minute walking test (6MWT) (time frame: From baseline to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03806387, which also lists 1 linked publication.

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 6 Sep 2023.

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