CompletedNot a drug-phase studyMS (type not specified)NCT03847545

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

What it measured

Main measures

  • Gait Profile Score (GPS) - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility

Other measures (10)

  • Gait Variable Scores (GVS) - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Functional test - 6 Spot Step Test (SSST)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Functional test - Timed 25 Footwalk (T25-FW)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Disability progressionWalking and mobility
  • Functional test - 2-minute Walk Test (2MWT)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Walking speed - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Step length - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Step width - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Stride length - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Cadence - (subgroup of 30 allocated to 3D gait analysis)

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility
  • Questionnaire - 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Danish version

    Baseline, 14 days (Change from baseline to 14 days follow-up)

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 100

Inclusion Criteria: * Fills the criteria for fampridine treatment * Fills the diagnostic McDonald criteria for MS * Age between 18 and 100 years * EDSS between 4 and 7 Exclusion Criteria: * Diagnosed epilepsy * MS attack or an acute decrease of functional capacity within the last 60 days * Change in immunomodulatory treatment within the last 60 days * Cancer within the last 5 years * Clinically significant systemic disease * Concurrent treatment with cimetidine, carvediol, propanolol and metformine

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Dec 2018

    2. Main results due

      Oct 2021

    3. Finished

      Oct 2021

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