Status unknownNot a drug-phase studyRelapsing MSNCT05730738

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

  • Dalfampridine ER, 10 Mg Oral Tablet, Extended Release

Placebo or sham

  • Placebo

What it measured

Main measures

  • gait

    at 3 months

    Disability progressionWalking and mobility
  • gait

    3 months

    Walking and mobility
  • Balance

    3 months

    Walking and mobility

Other measures (3)

  • cognition

    3 months

    Thinking and memory
  • fatigue

    3 months

    Thinking and memoryFatigue
  • Cognition

    3 months

    Thinking and memory

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: * Age > 18 years. * Individuals diagnosed with RRMS based on revised McDonald Criteria 2017 * Patients with Expanded Disability Status Scale (EDSS) ≤ 5.5 * Patients with gait impairment according to 25 foot walk test (25FWT) with cutoff ≥ 4 seconds Exclusion Criteria: * Women who are pregnant, intended to be pregnant or breastfeeding. * Past History of epilepsy or trigeminal neuralgia. * History of any psychiatric or medical illness affecting cognition and fatigue. * Other comorbidities that might affect gait. * Clinical relapse in the last three months. * Uncooperative patients or couldn't perform the required scales. * Patients with moderate to severe depression according to patient health questionnaire (PHQ-9) with cutoff point ≥15.

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

About this trial

In the sponsor's words

The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP). Fampridine penetrates the blood-brain barrier and improves impaired axonal conduction by selectively blocking potassium channels. Moreover, further studies investigated the possible beneficial effect of dalfampridine on cognitive functions and fatigue. The main objective of this study is to investigate the effect of dalfampridine on gait impairment, cognitive functions and fatigue in a sample of Egyptian patients with multiple sclerosis.

Papers

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Related trials

History

    1. Started

      Jun 2021

    2. Main results due

      Dec 2023

    3. Finished

      Dec 2024

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