Status:
COMPLETED
Central and Peripheral Nervous System Changes as Markers of Disease Progression in Multiple Sclerosis
Lead Sponsor:
University of Southern Denmark
Collaborating Sponsors:
Region of Southern Denmark
Conditions:
Multiple Sclerosis
Neurodegeneration
Eligibility:
All Genders
18-65 years
Brief Summary
OBJECTIVE To investigate neurodegeneration and demyelination in the central and peripheral nervous system in multiple sclerosis linked to disease progression and mechanisms that can explain different ...
Detailed Description
BACKGROUND Multiple Sclerosis (MS) is an autoimmune, inflammatory demyelinating disease targeting myelinated axons in the Central Nervous System (CNS). It is the most common nontraumatic cause of disa...
Eligibility Criteria
Inclusion
- Participants are diagnosed with MS according to the McDonald criteria.
- Categorized as responder or non-responder to Fampridine treatment.
- Age in the range of 18-65 years.
- Extended Disability Status Scale (EDSS) 4-7 points.
- Pyramidal Functions Score ≥ 2 in the Kurtzke Functional Systems Scores (FSS).
Exclusion
- MS-attack and/or change in immunomodulatory treatment within 60 days before inclusion.
- Simultaneous use of medications that inhibit the organic cation transporter (OCT2).
- History of epileptic seizures.
- Clinically manifest heart-, liver-, kidney- (glomerular filtration rate \< 80 ml/min), pulmonary disease, diabetes, alcohol intake exceeding the National Institute of Health's recommendations and pregnancy.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03401307
Start Date
August 1 2017
End Date
December 1 2020
Last Update
October 14 2021
Active Locations (1)
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1
Department of Neurology (Skleroseklinikken), Sygehus Sønderjylland
Sønderborg, Jylland, Denmark, 6400