CompletedPhase 4MS (type not specified)NCT02849782

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

  • 6 Minute Walk Test (6MWT)

    Timed 21 days

    Walking and mobility

Other measures (46)

  • Verbal fluencies

    Day 1

    Bladder, bowel and sexual function
  • Verbal fluencies

    7 days

    Bladder, bowel and sexual function
  • Verbal fluencies

    21 days

    Bladder, bowel and sexual function
  • Verbal fluencies

    28 days

    Bladder, bowel and sexual function
  • Verbal fluencies

    up to one year

    Bladder, bowel and sexual function
  • Symbol Digit Modalities Test

    Day 1

    Thinking and memory
  • Symbol Digit Modalities Test

    7 days

    Thinking and memory
  • Symbol Digit Modalities Test

    21 days

    Thinking and memory
  • Symbol Digit Modalities Test

    28 days

    Thinking and memory
  • Symbol Digit Modalities Test

    up to one year

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 80

Inclusion Criteria: * MS diagnostic regarding the modified McDonald criteria * EDSS status between 4.0 and 6.5 * patients able to walk during 6 minutes Exclusion Criteria: * increasing MS symptoms during the previous 60 days * history of epilepsy or epileptic seizure * immunotherapy change in the previous 60 days * beginning anti-spastic treatment in the previous 30 days * beginning treatment that is able to decrease fatigue symptoms in the previous 30 days * modification of the rehabilitation program during the study * renal insufficiency (creatinine clearance \<80ml.min-1 given by the Cockroft-Gault formula) * concomitant treatment by organic cation transporter 2 inhibitor * hypersensitivity to fampridine

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

About this trial

In the sponsor's words

This prospective monocentric open label trial was realized in the Laboratory of Clinical Functional Exploration of Movement at the University Hospital of Besancon. Cognitive evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation, respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1. Fampridine was prescribed according to guidelines issued by the French Health Products Safety Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were classified into 2 groups: responders whose clinical status was improved and non-responders whose clinical status was not improved.

Papers

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Related trials

History

    1. Started

      Feb 2014

    2. Main results due

      Mar 2019

    3. Finished

      Mar 2019

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