Central and Peripheral Nervous System Changes as Markers of Disease Progression in Multiple Sclerosis

Plain-language summary

This study investigates changes in the central and peripheral nervous system as markers of disease progression in multiple sclerosis (MS). Patients aged 18-65 diagnosed with MS according to the McDonald criteria, classified as responders or non-responders to Fampridine treatment, may take part. It was run as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University of Southern Denmark

Start date

8/1/2017

Estimated completion

12/1/2020

Countries

Denmark

Related genes

Locations

• Sønderborg, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

* 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.