CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Fampridinedrug
Likely dose
Fampridine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03847545
NCT03847545N/ACompleted

Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking

University of Southern Denmark·interventional·Posted Feb 20, 2019·Updated Apr 5, 2022

In Brief

A clinical study evaluating Fampridine for Multiple Sclerosis. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The primary study, as outlined in the original trial registration, aiming to use ultrasound speckle tracking (STU) to monitor muscle contractility in multiple sclerosis (MS) patients receiving vs. not receiving fampridine, as well as to relate these results to performance-based measures and biomarkers to explore disease progression and muscle activity, has been cancelled. Instead four exploratory studies that originate from the initial trial registration but with revised aims, outcome measures and time points, have been prepared - see the DEVIATIONS TO TRIAL PROTOCOL included in the Statistical Analysis Plan filed under "Document section". Summary of original trial registration: Despite effective treatments, the majority of patients with multiple sclerosis experience walking impairments to a degree where walking aids or a wheelchair is required. Since 2009, medical treatment of walking impairments has been possible with fampridine, which has proven effective in approximately 40% of the patients. At present, the treatment is offered on the basis of a measurable improved walking function evaluated by simple performance-based walking tests. The treatment is offered on the basis of a measurable improved walking distance. This is shown today using simple performance-based walking tests that are difficult to complete for those MS patients who are without gait function but could still benefit from fampridine treatment. Ultrasound speckle tracking is a non-invasive ultrasound technique, with the potential to measure muscle function, including muscle contractility (through strain). Ultrasound speckle tracking is designed for dynamic cardiac muscular examination, but can in a modified version be used for assessment of the skeletal muscles. The purpose of this project is to use ultrasound speckle tracking to monitor muscle contractility in MS patients receiving vs. not receiving fampridine treatment. Furthermore, to relate these results to biomarkers in blood and urine to examine disease progression and muscle activity.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 20, 2019
Enrollment StartDec 12, 2018
Primary CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.4 years ago

Interventions

Fampridinedrug

sustained-release tablet 10 mg morning and evening.