CompletedPhase 2Phase 3MS (type not specified)NCT05859802

What it found

No result found

We found no results in the registry or in papers.

This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Dalfampridine Pill

Placebo or sham

  • Placebo

What it measured

Main measures

  • MSQOL -54

    Baseline

    Quality of life (reported by participants)
  • MSQOL -54

    6 weeks

    Quality of life (reported by participants)
  • MSQOL -54

    12 weeks

    Quality of life (reported by participants)
  • Five time Sit to Stand

    Baseline

  • Five time Sit to Stand

    6 weeks

  • Five time Sit to Stand

    12 weeks

Other measures (12)

  • Symbol Digit Modalities Test

    Baseline

    Thinking and memory
  • Symbol Digit Modalities Test

    6 weeks

    Thinking and memory
  • Symbol Digit Modalities Test

    12 weeks

    Thinking and memory
  • Wheel chair to Mat transfers - Functional Independence Measure

    Baseline

  • Wheel chair to Mat transfers - Functional Independence Measure

    6 weeks

  • Wheel chair to Mat transfers - Functional Independence Measure

    12 weeks

  • Standing Tolerance

    Baseline

  • Standing Tolerance

    6 weeks

  • Standing Tolerance

    12 weeks

  • 9 Hole Peg Test

    Baseline

    Disability progression

Who could take part

MS (type not specified) · 20 and over

Inclusion Criteria: * Age 20 years or older confirmed MS diagnosis * Expanded Disability Status Scale (EDSS) of 7.0 or higher * No steroid treatment in the last 30 days or a relapse in the last 90 days, and MS considered stable * Capable of performing requirements of Physical Therapy (PT) treatment including at least a 2/5 manual muscle test in 50% or more of the major muscle groups Exclusion Criteria: * History of seizure disorder * Major cognitive or mental illness that prevented their ability to provide consent * Evidence of other medical cause of cognitive impairment besides MS * Severe joint contractures that limited the patients ability to move within full active range of motion

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

About this trial

In the sponsor's words

The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are: 1. Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone 2. Does Physical Therapy improve functional outcomes in patients who are non ambulatory

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Related trials

History

    1. Started

      Jul 2011

    2. Main results due

      Mar 2015

    3. Finished

      Jan 2016

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