NCT03806387

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

Completed Last updated 6 September 2023

What this trial tests

trial testing Alemtuzumab in Multiple Sclerosis in 17 participants. Completed in 30 June 2021.

Timeline

1 March 2017

Primary endpoint
30 July 2020

30 June 2021

Quick facts

Lead sponsor	University of Aarhus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	17
Start date	1 March 2017
Primary completion	30 July 2020
Estimated completion	30 June 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Alemtuzumab (ALEMTUZUMAB) — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University of Aarhus

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Hvid LG, Stenager E, Dalgas U. · · 2022 · cited 13× · PMID 35482080 · DOI 10.1007/s00415-022-11134-7