Status unknownPhase 4MS (type not specified)NCT02259361

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

Placebo or sham

  • Placebo

What it measured

Main measures

  • Nine-Hole Peg Test

    Changes in the Nine-Hole Peg Test from Baseline to end of Second week

    Arm and hand function
  • Nine-Hole Peg Test

    Changes in the Nine-Hole Peg Test from Baseline to end of first week

    Arm and hand function
  • Nine-Hole Peg Test

    Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase

    Arm and hand function

Other measures (12)

  • Box and Block test

    Changes in the Box and Block Test from Baseline to end of Second week

    Arm and hand function
  • Box and Block test

    Changes in the Box and Block Test from Baseline to end of first week

    Arm and hand function
  • Box and Block test

    Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase

    Arm and hand function
  • Isometric grip force and motor fatigue

    Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week

    FatigueArm and hand functionPhysical function
  • Isometric grip force and motor fatigue

    Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week

    FatigueArm and hand functionPhysical function
  • Isometric grip force and motor fatigue

    Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase

    FatigueArm and hand functionPhysical function
  • Sensory evaluation

    Changes in the Sensory evaluation Test from Baseline to end of Second week

  • Sensory evaluation

    Changes in the Sensory evaluation Test from Baseline to end of first week

  • Sensory evaluation

    Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase

  • Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)

    Changes in the DASH Test from Baseline to end of Second week

    Arm and hand function

Who could take part

MS (type not specified) · 18 to 70

Inclusion Criteria: 1. The patient must have the ability to understand the purpose and risks of the study provide a signed and dated informed consent and authorize confidential health information to be examined in accordance with national and local subject privacy regulations. 2. The patient must have been diagnosed with clinically definite MS, at the time of informed consent. 3. The patient must be between 18-70 years of age, inclusive, at the time of informed consent. 4. The patient must have scored between 50 and 90 on the upper limb Motricity Index test, at the time of informed consent. This test evaluates strength during three essential movements (pinch grasp, elbow flexion and shoulder abduction). The selected score range criteria determine patients who suffer a moderate decline in function abilities of the upper limb. Exclusion Criteria: 1. Onset of multiple sclerosis exacerbation within 60 days of screening. 2. History of seizures or evidence of epileptic form activity found on a screened electroencephalogram. 3. Changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the study.

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

About this trial

In the sponsor's words

This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Nov 2014

    2. Main results due

      Nov 2014

    3. Finished

      Nov 2014

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