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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT03806387
• Date of registration: 09/01/2019
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment
• Scientific title: Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study
• Date of first enrolment: March 1, 2017
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03806387
• Study type: Observational

Countries of recruitment

Denmark

Contacts

• Name: Ulrik Dalgas, MSc,PhD
• Affiliation: Aarhus University, Health, Section for Sport Science

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Alemtuzumab

Primary Outcome(s)

Six minute walking test (6MWT) [Time Frame: From baseline to 24 months]

Secondary Outcome(s)

Body composition - whole body lean mass [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Multiple Sclerosis Impact Scale (MSIS-29) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Clinical Severity of Disease [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Physical activity [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Relapse frequency [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Selective Reminding Test (SRT) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Symbol Digit Modalities Test (SDMT) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Stair Climbing test [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

12-item Multiple Sclerosis Walking Scale (MSWS-12) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Hospital Anxiety and Depression Scale (HADS) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Maximal muscle strength [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Modified Fatigue Impact Scale (MFIS) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

5 times sit to stand test (5STS) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Body composition - limb fat mass [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Body composition - limb lean mass [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Neuromuscular activation [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Body composition - whole body fat mass [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Maximal oxygen uptake (VO2 max) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Six minute walking test (6MWT) [Time Frame: From baseline to 3 months, 6 months, and 12 months]

Six Spot Step Test (SSST) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Timed 25 foot walk (T25FWT) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Timed Up and Go (TUG) [Time Frame: From baseline to 3 months, 6 months, 12 months, and 24 months]

Secondary ID(s)

MS_Improve

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genzyme, a Sanofi Company